Class 2 Device Recall Invacare TDX SP2

• Date Initiated by Firm: March 30, 2022
• Create Date: May 25, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1130-2022
• Recall Event ID: 90084
• 510(K)Number: K170507
• Product Classification: Wheelchair, powered - Product Code ITI
• Product: Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
• Code Information: UDI (DI): Model Number Device Identifier TDXSP2 00841447100911 TDXSP2-MCG 00841447100966 TDXSP2V 00841447101512 Serial Numbers: 22CE000031 22BE004288 22BE002669 22BE003672 22BE004782 22BE004151 22CE000984 22BE004286 22BE004171 22BE004540 22CE001086 22BE003661 22CE000184 22CE000878 22CE001449 22CE000032 22CE001421 22BE004933 22CE001002 22CE000180 22CE000725 22BE004544 22BE005009 22BE003671 22BE004284 22BE004159 22BE004285 22BE002652 22BE004282 22BE004798 22BE004281 22BE004170 22CE000182 22CE000183 22CE000876 22CE000873 22CE000981 22CE000870 22CE000871 22CE001248 22CE001004 22CE001084 22BE004776 22BE004165 22BE004931 22BE005010 22CE000875 22CE000728 22CE000727 22BE004910 22BE004904 22BE005007 22BE004160 22BE004169 22BE004175 22BE004166 22BE004905 22CE001420 22CE000496 22BE003645 22BE002651 22CE000999 22CE001078 22BE004545 22BE004763 22BE003662 22BE004929 22BE004937 22BE004176 22BE004903 22CE000181 22BE004167 22BE005006 22BE002666 22BE004177 22BE003962 22BE003957 22BE004173 22BE003664 22BE003659 22BE004767 22BE004940 22BE004777 22BE004538 22CE000186 22CE000867 22BE002935 22BE003959 22CE000493 22CE001077 22BE002934 22CE000726 22BE005004 22CE001251 22BE003961 22BE003673 22BE004902 22BE002936 22BE004801 22BE004287 22BE004995 22BE004539 22CE001075 22CE000490 22CE000879 22BE004168 22CE000847 22CE000033 22CE001005 22CE001006 22BE004765 22BE004768 22BE004769 22BE004770 22BE004911 22BE002932 22BE003960 22CE000874 22CE001253 22BE004930 22CE000178 22CE000179 22CE001080 22BE004174 22BE003963 22BE004935 22BE004775 22BE004172 22CE000177 22BE004543 22BE004764 22BE004766 22CE001076
• Recalling Firm/ Manufacturer: Invacare Corporation; 1200 Taylor St; Elyria OH 44035-6248
• For Additional Information Contact: Invacare Support Line; 877-413-6008
• Manufacturer 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.
• FDA Determined 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 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
• Quantity in Commerce: 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.
• 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