Device product
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Z-0302-2022
Product summary
- Event
- Event 88962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0302-2022
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: 122025 122012 122022 122021 122005 121209 122017 122001 134500 122010 122007 122016 122013 122024 122014
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