All Recalls

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Distribution without premarket approval/clearance.

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.