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

Recall Z-0514-2021 — Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

U.S. FDA — Device Enforcement · United States · 2020-10-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0514-2021
Date of alert
2020-10-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Invacare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00841447100249
Reported risk: Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
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.

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