Z-2065-2019Class I

Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1

Name: Z-2065-2019 Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1
Creator: Fenwal Inc
Published: 2019-06-24
License: https://open.fda.gov/license/

Fenwal Inc / initiated 2019-06-24 / Terminated / root cause: software

FDA source

Fenwal Inc began a 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 that, when used in... on 2019-06-24. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2065-2019
Classification: Class I
Status: Terminated
Initiated: 2019-06-24
Posted: 2019-08-12
Terminated: 2023-03-06
Recalling firm: Fenwal Inc
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.).
Product code: PHC Infusion Safety Management Software
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
Root cause tag: software
FDA root cause: 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
Product codes and lots: All serial numbers distributed in the US

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2065-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2064-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2065-2019	Class I	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12

Product code PHC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)