All Recalls

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.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

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.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.

Potential issue where the IntelliVue monitors did not alarm.

Distribution without premarket approval/clearance.

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Distribution without premarket approval/clearance.

Distribution without premarket approval/clearance.