Date Initiated by Firm | June 24, 2019 |
Date Posted | August 12, 2019 |
Recall Status1 |
Terminated 3 on March 06, 2023 |
Recall Number | Z-2065-2019 |
Recall Event ID |
83138 |
Product Classification |
Infusion safety management software - Product Code PHC
|
Product | Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1
Product Usage:
Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.). |
Code Information |
All serial numbers distributed in the US |
Recalling Firm/ Manufacturer |
Fenwal Inc 3 Corporate Dr Ste 300 Lake Zurich IL 60047-8930
|
For Additional Information Contact | 800-333-6925 Ext. 3 |
Manufacturer Reason for Recall | The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib |
FDA Determined Cause 2 | Other |
Action | The firm initiated the recall by letter on 06/24/2019. The letter describes the issues and provided supplemental instructions to be implemented until the new software is installed.
The firm issued a press release on 06/28/2019. |
Quantity in Commerce | 83 units |
Distribution | US Nationwide Distribution |
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.
|