Class 2 Device Recall Invacare PerfectO2 V Oxygen Concentrator

• Date Initiated by Firm: October 30, 2020
• Create Date: December 01, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0514-2021
• Recall Event ID: 86604
• 510(K)Number: K200890
• Product Classification: Generator, oxygen, portable - Product Code CAW
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-6248
• For Additional Information Contact: Invacare Support; 440-329-6595
• Manufacturer 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.
• FDA Determined 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 Repair Instructions provided on the www.Invacare.com/RC928 website. 4. Order field correction service kits and conduct field correction repair activities on affected devices during their next regularly scheduled maintenance service. Details on how to order the service kits are provided on the website www.Invacare.com/RC928. 5. Field correction repairs must be completed on affected units before October 30, 2021. If you currently use a service provider for maintenance and repair, they can execute this field action service. 6. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. We recommend that you provide them with the Consumer Letter provided on the www.Invacare.com/RC928 website. Invacare provided copies of the US and Canada notification letters to Invacare Europe for their reference and distribution.
• Quantity in Commerce: 384,767 units
• Distribution: Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAW