Recall Z-0514-2021 ยท CAW Generator, Oxygen, Portable
Invacare Corporation
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
| Date | Oct 30, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Invacare issued Urgent Notification letter on 10/30/20 to providers and consumers via email stating reason for recall, health risk and action to take: Visit www.Invacare.com/RC928 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of affected device serial numbers sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units. 2. Review your existing stock to locate the affected devices. 3. Review the Repai |
| Quantity | 384,767 units |
| Distribution | Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200890 | Invacare Perfecto2V Oxygen Concentrator Invacare Corporation, Aug 6, 2020 |