Generator, Oxygen, Portable

React Health PHOENIX 5L Oxygen Concentrator

Devices which did not meet internal quality specifications were inadvertently distributed.

SimplyGo Mini, Standard Battery Kit;

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

Oxygen concentrator may melt or catch on fire during use.

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.