Device product
UroDiagnost Eleva, system code 708033
Z-1492-2020
Product summary
- Event
- Event 84756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-1492-2020
Official wording
Reason: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Code information: Serial numbers 64 48 2 60
Distribution pattern: Nationwide domestic distribution. Foreign distribution worldwide.
Derived failure modes
-
Unknown
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.