Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
FDA Recall Z-1130-2022 · Posted None
Recalling FirmInvacare Corporation
Recall StatusOpen, Classified
Product CodeITI
Date Initiated2022-03-30
Product Quantity133 devices
Reason for Recall
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.
Firm Action
A preliminary notification was sent to providers on March 30, 2022, introducing the product issue and providing instructions regarding how to handle impacted units before field correction kits are available.
A notification letter dated April 13, 2022, was sent to impacted consignees via traceable mail. This mailing includes a Provider Letter which will introduces the field correction requirements and provides instructions for acknowledging awareness and understanding of the requested field correction activities.
Providers should inform affected customers to inform them that their wheelchair is subject to recall and requires repair. The letter provides user precautions that must be taken until the wheelchair is repaired.
If you have any questions concerning this recall, please call Invacare s field correction support line at (877) 413-6008
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.