Date Initiated by Firm |
January 10, 2012 |
Create Date |
October 16, 2019 |
Recall Status1 |
Terminated 3 on April 19, 2024 |
Recall Number |
Z-0155-2020 |
Recall Event ID |
83582 |
510(K)Number |
K973628
|
Product Classification |
Analyzer, chemistry, micro, for clinical use - Product Code JJF
|
Product |
Viva-E, Catalog # 6002-380, UDI # 03661540600050
Product Usage: automated chemistry analyzer intended for clinical use |
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. |
Recalling Firm/ Manufacturer |
Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
The firm reached out to consignees via phone to inform them of the affected product. |
Quantity in Commerce |
75 units |
Distribution |
US Nationwide in the states of NY, and UT |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JJF and Original Applicant = VITAL SCIENTIFIC N.V.
|