Device product
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Z-1871-2024
Product summary
- Event
- Event 94536
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1871-2024
Official wording
Reason: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
Code information: UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity