Device product
Artis zee systems x-ray, angiographic system
Z-0172-2014
Product summary
- Event
- Event 65795
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-0172-2014
Official wording
Reason: The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Code information: model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
Distribution pattern: US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Derived failure modes
-
Unknown
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.