FDA Medical Device Recalls (openFDA)
Invacare Corporation: Pronto Series Power Wheelchair, model M50.
- Recall number
- Z-0901-05
- Recalling firm
- Invacare Corporation
- Product
- Pronto Series Power Wheelchair, model M50.
- Status
- Terminated
- Initiated
- 2005-05-02
- Posted
- 2005-06-17
- Terminated
- 2008-01-04
- Reason
- If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
- Root cause
- Other
- Action
- The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.
- Quantity
- 1 device.
- Distribution
- The product was sent to consignees located in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. There was one foreign consignee in France: Poirer, Zac Papillon, 3720 Parcay Meslay, Corps, France
- Lot, serial or model codes
- All serial numbers between 05A000-05C999.
- 510(k) numbers
- ["K021680"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 3002889431
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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