Invacare Corporation: Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All Wor

Is my product affected?

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

• UPC 00841447100249

Check against the official notice below — it lists the full affected range.

What happened

Invacare Corporation is recalling approximately 384,767 PerfectO2 V Oxygen Concentrators distributed worldwide, including units in the US, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands. The devices, intended for patients with respiratory disorders requiring supplemental oxygen, may experience breakdown of the sound abatement washer and metal-on-metal wear inside the Pressure Equalization valve assembly, which can lead to device failure resulting in self-extinguishing fires or cap explosions.

The recall affects multiple model numbers and serial number ranges: IRC5PO2V (Serial # 14HF039890 to 18JF007415), IRC5PO2VC (Serial # 14IF004028 to 18JF028633), IRC5PO2VAW (Serial # 17HF030338 to 18IF018522), IRC5PO2VAWL2 (Serial # 18BF007341 to 18IF024451), IRC5PO2VAWL3 (Serial # 17JF002563 to 19AF008559), and IRC5PO2VAWL5 (Serial # 18EF003466 to 18EF003544). The source record does not specify what remedy affected consumers should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands Quantity: 384,767 units Lot/code info: Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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