Recalls

Cribs sold in the USA are missing two access door warning labels.

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion.

Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.

The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.

CPU board failures cause fowler (backrest) electronic controls to stop working.

Customer complaints associated with faulty brake system

Inaccurate scale systems

Potential for power cord to melt; hazards include electric shock and fire.

Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec

Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to

Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.

Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.

It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.

Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; indicating a blockage within the LAL tubi

Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.

Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes.

Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.

Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentation and classification.

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int

The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.

Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanently engage the track locking mechanism

This recall was initiated as the firm ascertained the supplier may have reworked some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical intervention.

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa

Affected mattresses may not conform to federal flammability standards.

The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures.

The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.

The Fowler mechanism may malfunction, preventing it from being lowered into a flat position.

The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inopperable over time with excessive wear of the brass nut.

The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with excessive wear of the brass nut. T

The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with excessive wear of the brass nut. T

The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The brake/steer pedal may seize, resulting in the brakes not working.

The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.

The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The backrest of the bed may not stay in an upright position (may drift down when left raised).

The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.

The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler.

The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features.

The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features.

The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho

The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

The brakes may not have adequate holding power to lock the bed in place.

The brakes may not have adequate holding power to lock the bed in place.

The brakes may not have adequate holding power to lock the bed in place.

The brakes may not have adequate holding power to lock the bed in place.

The brakes may not have adequate holding power to lock the bed in place.

Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re

Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may have an overdrive problem which could re

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.

The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.

An incorrect pin may have been used during assembly and therefore the device may give way during use.

The bed exit may not alarm as appropriate.

The bed exit may not alarm as appropriate.

Trendelenburg and reverse trendelenburg features may not function.

Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.

Users may be pinched in the siderail assembly when raising or lowering the siderail.

A potential shock hazard exists if the night light is damaged.

A potential shock hazard exists if the night light is damaged.

A potential shock hazard exists if the night light is damaged.

The user may be pinched by the siderail when raising or lowering the siderail.

A wire may break at the crimp and present a potential electric shock hazard.

Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter

It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached

It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).

The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.

The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.

Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.

The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we

The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Ambulance Cots may not meet crash test standard BS EN 1789

Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed retract and then a few moments later i

The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR

Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.