Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2064-2019 — VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a 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 adul

U.S. FDA — Device Enforcement · United States · 2019-06-24 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2064-2019
Date of alert: 2019-06-24
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Fenwal Inc
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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