Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mo
Summary
The FDA issued a Class II for Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Nu by Invacare Corporation. Reason: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rat.
Details
Source
Device Recall
External ID
Z-0445-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
Lot/Code Info: LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: TDXSP2 00841447100911 TDXSP2-CG 00841447100942 TDXSP2-MCG 00841447100966 TDXSP2HD 00841447108641 TDXSP2HD-CG 00841447111207 TDXSP2HD-MCG 00841447111214 TDXSP2V 00841447101512 TDXSP2V-HD 00841447102052 TDXSP2X-CG 00841447101000 TDXSP2X-MCG 00841447101017
Quantity Affected: 1477 units US; 1226 units OUS
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-12
Company
Elyria, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Invacare Corporation has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Invacare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Invacare Corporation have FDA actions?
Invacare Corporation has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0445-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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