Z-0362-2019Class II

Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The...

Name: Z-0362-2019 Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The...
Creator: Fresenius Vial Sa
Published: 2017-12-02
License: https://open.fda.gov/license/

Fresenius Vial S.A.S. / initiated 2017-12-02 / Terminated / root cause: software

FDA source

Fresenius Vial Sa began a recall of Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical... on 2017-12-02. FDA classified it as Class II and gives the reason as "Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions". 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-0362-2019
Classification: Class II
Status: Terminated
Initiated: 2017-12-02
Posted: 2018-11-02
Terminated: 2021-02-11
Recalling firm: Fresenius Vial S.A.S.
Product: Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. 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).
Product code: FRN Pump, Infusion
Reason for recall: Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.
Root cause tag: software
FDA root cause: Software design
Action: A recall notification dated 11/17/17 was sent to customers to inform them that Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump. The new software version 1.9a is currently available and designed to improve customer experience while preventing common software malfunctions. Customers will be contacted by a Fresenius Kabi service representative or distributor to schedule a service appointment for upgrading the software. Customers with any questions or require additional information are instructed to contact the Fresenius Kabi Technical Hotline at (800) 937-5060.
Quantity in commerce: 7082 units
Distribution: Worldwide distribution - US Nationwide and countries of Canada and China.
Product codes and lots: Model Catalog Z021135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0362-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0362-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01

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)