Recall Z-1201-2012 ยท ITI Wheelchair, Powered
Invacare Corporation
TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation, Elyria, OH 44035 The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-
| Date | Mar 12, 2012 (initiated Feb 10, 2012) |
| Status | Terminated |
| Reason | Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Invacare, sent an "URGENT: RECALL INFORMATION" letter dated February 10, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. Invacare has developed retrofit kits intended to address this issue. The consignees were instructed to contact the customers that have potentially affected product and perform the necessary updates. The consignees were also instructed to complete and return the Provider Response Form to order the retrofit kit. If you have any questions, please contact Customer Service at 1-800-333-6900. |
| Quantity | 102 wheelechairs |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AZ, CA, CT, FL, GA, IA, IL, IN, KY, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, RI, SD, TX, VA, WA, and WI; and countries of: Australia, Canada and New Zeland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023589 | STORM TDX POWER WHEELCHAIR Invacare Corp., Nov 19, 2002 |