Z-2064-2019Class I

VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a

Name: Z-2064-2019 VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a
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 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... 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-2064-2019
Classification: Class I
Status: Terminated
Initiated: 2019-06-24
Posted: 2019-08-12
Terminated: 2023-03-06
Recalling firm: Fenwal Inc
Product: 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.
Product code: FRN Pump, Infusion
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: 9461 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-2064-2019
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 FRN

K121613Class IIAgilia Infusion SystemFresenius Kabi AG / cleared 2013-05-01

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)