Device product
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
Z-0304-2022
Product summary
- Event
- Event 88962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0304-2022
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 111502 111503 111510 111507 111512 111508 111133 111504 111506 111513 111500 111501 111505 111514
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