Recalls for Coil, Magnetic Resonance, Specialty

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential for coils to heat up and harm patients (burn).

Potential for coils to heat up and harm patients (burn).

Potential for coils to heat up and harm patients (burn).

Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. If a second and compounding issue of improperly routed Rear Pedestal Air Supply Hose is also present, routed in such a way to cause the hose to come in contact with the overheated gradient lead

The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.

Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.

The firm received a complaint indicating that the mirror is high risk and could drop on a patient.

The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.

The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.

Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.

The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. This could result in user and/or patient contact with infectious agents since the internal porous material cannot be disinfected.

The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.

A diode was inadvertently not assembled into the system, which may result in coil overheating