Recall Z-0903-05 ยท ITI Wheelchair, Powered
Invacare Corporation
Pronto Series Power Wheelchair, model M61.
| Date | Jun 17, 2005 (initiated May 2, 2005) |
| Status | Terminated |
| 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 | 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, and WV. There was one foreign consignee in France: Poirer, Zac Papillon, 3720 Parcay Meslay, Corps, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021680 | INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 Invacare Corp., Jun 18, 2002 |