Device product
Artis zee and Artis zeego systems. x-ray, angiographic system
Z-2569-2014
Product summary
- Event
- Event 68704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 206
- Official record key
device-enforcement:Z-2569-2014
Official wording
Reason: There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
Code information: running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
problem with Artis zee and Artis zeego systems running software