Lower riskMedical device recall · FDA · Published June 24, 2019
Fenwal Vigilant Drug Lib Software Recall: Dose Error Risk
Fenwal recalls Vigilant Drug Lib software versions 1.0 and 1.1 due to potential dose errors in patient medication administration. This software works with Volumat MC Agilia infusion pumps to reduce errors but requires specific patient weight ranges.
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
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Contact the company
📍Recalling firmFenwal Inc3 Corporate Dr Ste 300 · Lake Zurich, IL 60047-8930
✎ GovInfoNow plain-language explainer
Fenwal is recalling Vigilant Drug Lib software versions 1.0 and 1.1 that can cause dose errors when used with Volumat MC Agilia infusion pumps. This software is designed to reduce medication errors but may not function correctly for patients outside the specified weight range. Read more at govinfonow.com/recall/67607-fenwal-vigilant-drug-lib-software-recall-dose-error-risk.
“Fenwal Vigilant Drug Lib Software Recall: Dose Error Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67607-fenwal-vigilant-drug-lib-software-recall-dose-error-risk. Based on FDA recall #Z-2065-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2065-2019%22&limit=1).
Fenwal Inc recalled Vigilant Drug'Lib software versions 1.0 and 1.1 nationwide due to potential dose errors, according to the FDA on June 24, 2019.
How to tell if you have it
Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1
The hazard
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.
Context
GovInfoNow's records show Fenwal Inc has had four other recalls since Feb. 11, 2019. Other recent recalls include a Feb. 14, 2023 recall for Amicus Exchange Kits due to stress leaks and a March 5, 2019 recall for CATSmart devices involving tubing puncture risks. Similar product recalls include a Dec. 15, 2025 Broselow Domestic Complete ALS Organizer Software recall for dosing errors and an Aug. 11, 2026 Baxter Novum IQ Syringe Pump recall for software issues.
How to tell if you have this one
Check for Vigilant Drug Lib software versions 1.0 and 1.1 installed on Volumat MC Agilia infusion pumps. The software is intended for patients weighing between 0.6 lbs and 551 lbs.
Brand
Fenwal
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
Distribution
US Nationwide Distribution
Recall number
Product, codes & lots
Quantity
Z-2064-2019
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.; All serial numbers distributed in the US
9461 units
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 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.).; All serial numbers distributed in the US
83 units
Based on the official FDA remedy
What to do — step by step
Update Software
Install the corrected software version from Fenwal to ensure proper dose calculations for patients within the specified weight range.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2065-2019 (June 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2065-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.