The Recall Desk
ModerateFDA (Devices)·Z-0362-2019·Announced 2018-11-07

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pumps for Software Upgrade

Fresenius Kabi is recalling 7,082 Volumat MC Agilia Volumetric Infusion Pumps to install a mandatory software upgrade that prevents common software malfunctions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary measure to prevent common software malfunctions and improve customer experience, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Fresenius Kabi has initiated a mandatory software upgrade for the Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. The recall involves 7,082 units that were distributed worldwide, including in the United States, Canada, and China.

The recall was initiated because the software upgrade is designed to improve the customer experience while preventing common software malfunctions. The device is a transportable medical equipment intended for use in healthcare facilities by trained professionals to administer parenteral fluids, medications, and blood products to adults, pediatrics, and neonatal patients.

Healthcare facilities should contact the manufacturer to arrange for the mandatory software upgrade. No specific illnesses or injuries are reported in the source text.

The recalled product

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 hospi
Manufacturer
Fresenius Vial Sa
Category
Medical Device — Infusion Pump
Hazard
Affected units
7,082

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Catalog Z021135

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · software malfunction

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