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).
Recall
- Recall Number
- Z-0362-2019
- Event Number
- 81208
- Firm
- Fresenius Vial Sa Le Grand Chemin Brezins France
- FEI Number
- 3000240707
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 2, 2017
- Terminated
- February 11, 2021
Description
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).
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.
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.
Worldwide distribution - US Nationwide and countries of Canada and China.
7082 units