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Invacare Perfecto2 Oxygen Concentrator recallZ-0514-2021 · Invacare Corporation · initiated Oct 30, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Invacare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0514-2021
Status
Terminated
Initiated by the company
Oct 30, 2020
Recalling firm
Invacare Corporation
Quantity
384,767 units
Product code
CAW
FDA submissions
K200890
Distribution
Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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