FDA Medical Device Recalls (openFDA)
Invacare Corporation: Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
- Recall number
- Z-0579-2010
- Recalling firm
- Invacare Corporation
- Product
- Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
- Status
- Terminated
- Initiated
- 2009-09-15
- Posted
- 2009-12-29
- Terminated
- 2014-08-25
- Reason
- For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for
- Root cause
- Device Design
- Action
- On 9/15/2009 the firm sent recall notification letter to their customers instructing them to immediately contact the dealer to have the stability lock inspected and/or adjusted. If the dealer is unavailable or the repair will take longer than 60 days, they are to contact the firm and arrange for an inspection and/or adjustment. Invacare requested contact names to whom it can send additional information. Invacare plans to mail, via FEDEX, information regarding the recall to each consignee. Initial consignees received a response card and instructions to forward cards to any customer to whom they have distributed the product. The products are to be inspected at the cylinder label and if the label does not have a long alpha-numeric string demonstrated in the label, the cylinders on the chair have to be replaced. Questions are directed to Recalls@Invacare.com or to 800-333-6900.
- Quantity
- 36
- Distribution
- Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.
- Lot, serial or model codes
- Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.
- 510(k) numbers
- ["K023589"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 1525712
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28