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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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.
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