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

Recall Z-2273-2013 — Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by deliveri

U.S. FDA — Device Enforcement · United States · 2013-09-05 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2273-2013
Date of alert: 2013-09-05
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Carefusion 211 Inc dba Carefusion
Product category: device
Product type: Devices

Reported risk: CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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