Recall Z-0362-2019 ยท FRN Pump, Infusion
Fresenius Vial Sa
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 multip
| Date | Dec 2, 2017 |
| Status | Terminated |
| Reason | 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 | 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 Hot |
| Quantity | 7082 units |
| Distribution | Worldwide distribution - US Nationwide and countries of Canada and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121613 | AGILIA INFUSION SYSTEM Fresenius Kabi AG, May 1, 2013 |