Device product
Artis zee, Angiographic x-ray system
Z-1824-2017
Product summary
- Event
- Event 76869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units distributed in U.S.
- Official record key
device-enforcement:Z-1824-2017
Official wording
Reason: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
Code information: Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744
Distribution pattern: Distributed to: VA, CA, WI
Derived failure modes
-
Device software or design
Software error - As a result of a software fault