Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 55 recalls
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Potential for incomplete scan due to unstable connection inside of floating sensor.
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…
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…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…
Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2.…