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).
FDA Recall Z-0362-2019 · Posted None
Recalling FirmFresenius Vial Sa
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-12-02
Date Terminated2021-02-11
Product Quantity7082 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide and countries of Canada and China.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.