TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation
FDA device recall Z-1201-2012 · posted 2012-03-12 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 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, Canad
- Date initiated
- 2012-02-10
- Date posted
- 2012-03-12
- Date terminated
- 2014-08-25
- Location
- Elyria, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STORM TDX POWER WHEELCHAIR (K023589) | Invacare Corp. | 2002-11-19 |