Device product
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Z-0297-2022
Product summary
- Event
- Event 88962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0297-2022
Official wording
Reason: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Code information: Serial Numbers: Serial 150002 150017 125700 150005 150023 150009 150015 150003 Expanded Recall 11/15/21: 147120 147119 150011
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure