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U.S. Department of Health and Human Services

Class 1 Device Recall Vigilant Agilia, Vigilant Drug'Lib

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  Class 1 Device Recall Vigilant Agilia, Vigilant Drug'Lib see related information
Date Initiated by Firm June 24, 2019
Create Date August 12, 2019
Recall Status1 Open3, Classified
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
Nonconforming Material/Component
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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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