Recall Z-1130-2022— Invacare Corporation

Name: FDA recall Z-1130-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Ongoing

Class II FDA medical device recall by Invacare Corporation, initiated 2022-03-30. It names one FDA 510(k) clearance: K170507. Product: Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V. 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..

Recalling firm: Invacare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-03-30
Firm location: Elyria, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K170507 — Invacare® TDX® SP2 Power Wheelchair +1 moreInvacare Corporation·cleared 2017-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.