Medical Devices Recalls

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

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

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

Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

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

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.