Pronto Series Power Wheelchair, model M61.
FDA device recall Z-0903-05 · posted 2005-06-17 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 137 devices.
- 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, an
- Date initiated
- 2005-05-02
- Date posted
- 2005-06-17
- Date terminated
- 2008-01-04
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 (K021680) | Invacare Corp. | 2002-06-18 |