Recall Z-1130-2022 · ITI Wheelchair, Powered
Invacare Corporation
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
| Date | Mar 30, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 |
| Quantity | 133 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System Invacare Corporation, Jul 12, 2017 |