Fenwal recalls Volumat MC Agilia infusion pumps with software versions 1.7 and 1.9a due to four software anomalies and KVO alarm priority issues. Affected units may need software updates to prevent potential infusion errors.
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
Fenwal is recalling Volumat MC Agilia infusion pumps with specific software versions (1.7 and 1.9a) because they have software issues that could lead to incorrect medication delivery. This recall is important for healthcare professionals using these pumps to ensure safe patient treatment.
The software versions 1.7 and 1.9a have four anomalies that could affect how the pump handles medication delivery. Additionally, there is a KVO (keep vein open) end of infusion alarm priority issue that might not alert healthcare staff properly during critical moments.
Healthcare professionals using Volumat MC Agilia infusion pumps with software versions 1.7 and 1.9a in the US. Patients receiving medication through these pumps are at risk if the software issues cause incorrect dosing.
Check if your Volumat MC Agilia infusion pump has software versions 1.7 or 1.9a. The product was sold in the US with all serial numbers.
Review your pump's software version to see if it is 1.7 or 1.9a.
Fenwal is correcting four software anomalies and KVO end of infusion alarm priority issues in software versions 1.7 and 1.9a that could affect medication delivery safety.
No, the recall does not require immediate stoppage. Healthcare professionals can continue using the pump with the current software versions until they update to a corrected version.
The official recall notice does not specify software update instructions. Contact Fenwal directly for guidance on updating the software to a corrected version.
We’ve drafted a message you can send Fenwal to request your refund or repair — edit it as you like.
Subject: Recall Z-2064-2019 — Fenwal Fenwal Hello, I own a Fenwal that is covered by recall Z-2064-2019 from Fenwal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
