Z-0155-2020 Class II Terminated
FDA device recall Z-0155-2020 was initiated by Vital Scientific N.V. on January 10, 2012 and is designated Class II. Reason for recall: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. The recall status is terminated (terminated April 19, 2024). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- January 10, 2012
- Termination Date
- April 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Reason for Recall
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Distribution Pattern
US Nationwide in the states of NY, and UT
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.