All Recalls

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.

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.

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

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 have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

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.

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

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.

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

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.

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

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

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

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.

Undeclared egg