Other Medical Devices

Labeling contains claims that are not consistently present.

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.

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.

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.

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.

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.

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

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.

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.

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

Product testing did not meet expected stability criteria.

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.