Vital Scientific N.V.: Medical Device Recall in 2019 - (Recall #: Z-0155-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

Product Classification:

Class II

Date Initiated: January 10, 2012
Date Posted: October 23, 2019
Recall Number: Z-0155-2020
Event ID: 83582
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.

Status: Terminated
Product Quantity: 75 units
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

Voluntary or Mandated:

Voluntary: Firm initiated