FDA Medical Device Recalls (openFDA)
Vital Scientific N.V.: Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- Recall number
- Z-0155-2020
- Recalling firm
- Vital Scientific N.V.
- Product
- Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- Status
- Terminated
- Initiated
- 2012-01-10
- Posted
- not on file
- Terminated
- 2024-04-19
- Reason
- The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Root cause
- Component design/selection
- Action
- The firm reached out to consignees via phone to inform them of the affected product.
- Quantity
- 75 units
- Distribution
- US Nationwide in the states of NY, and UT
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K973628"]
- PMA numbers
- not on file
- Product code
- JJF
- Firm FEI
- 2708
- Firm city
- Dieren
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28