Class 2 Device Recall Invacare

• Date Initiated by Firm: November 12, 2021
• Create Date: January 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0447-2022
• Recall Event ID: 89062
• 510(K)Number: K202379
• Product Classification: Wheelchair, powered - Product Code ITI
• Product: Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
• Code Information: LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: SRX-20MP 00841447114581 SRX-20R 00841447114604 SRX-20SP 00841447114598
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-6248
• For Additional Information Contact: Invacare Corporation; 877-413-6008
• Manufacturer Reason for Recall: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
• FDA Determined Cause: Software design
• Action: Invacare issued Urgent Medical Device Letter issued on 11/12/21 to consignees who received devices with LiNX Gyro modules containing firmware version 6.1.2. This letter also contains instructions for consignees who upgraded devices in the field to version 6.1.2. A Consumer Letter will be provided on the recall website for Providers to send to end users who are impacted. Letter states reason for recall, health risk and action to take: Visit www. Invacare.com/RC916 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of power wheelchair serial numbers and/or LiNX Gyro Modules 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. " The account number required to access your list of impacted devices appears directly at the end of your company name in the mailing address. For example, ABC COMPANY-XXXXX. " The mailing postal code will also be required to log into your account. 2. Stop using LiNX Gyro Module firmware version 6.1.2 on all power wheelchair programming tools and stored electronic media. 3. Immediately update any LiNX Access iOS and LiNX Access PC tools containing LiNX Gyro Module firmware version 6.1.2 to the latest LiNX Access iOS or LiNX Access PC tool version. 4. Locate the power wheelchairs with affected LiNX Gyro Modules per the date ranges above. 5. For power wheelchairs built prior to the date ranges above, review your customer records to identify whether you have installed LiNX firmware version 6.1.2 on any LiNX Gyro-equipped power wheelchairs since the January 14, 2021 release date of firmware version 6.1.2. Note: If you do not have record of the firmware version installed on the LiNX Gyro Modules you have purchased from Invacare, you must connect to the LiNX system on the wheelchair using the LiNX Access tool to determine the firmware version of the Gyro
• Quantity in Commerce: 1 unit US
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
• 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 = ITI