FDA Device recall Z-2065-2019
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software tha…
- FDA Device
- Class I
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class I recall of Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software tha… by Fenwal, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2065-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-06-24 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Fenwal |
| Distribution | US |
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.).
Reason
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
Identifiers
| code_info | All serial numbers distributed in the US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2065-2019%22
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