Device product
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Z-0155-2020
Product summary
- Event
- Event 83582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0155-2020
Official wording
Reason: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Code information: serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.
Distribution pattern: US Nationwide in the states of NY, and UT
Derived failure modes
-
Unknown
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.