Medical Devices Recalls

Potential risk for helium gas inside the MR examination room during a magnet quench

Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

Surview scan with tube current lower than 30 mA is unable to be initialized.

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Potential risk for helium gas inside the MR examination room during a magnet quench

Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..

Potential risk for helium gas inside the MR examination room during a magnet quench

Potential risk for helium gas inside the MR examination room during a magnet quench

NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.