Z-0903-05
Pronto Series Power Wheelchair, model M61
Invacare GmbH / initiated 2005-05-02 / Terminated / root cause: supplier
Invacare Corporation began a recall of Pronto Series Power Wheelchair, model M61 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.
Recall record
- Recall number
- Z-0903-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Invacare GmbH
- Product
- Pronto Series Power Wheelchair, model M61.
- Product code
- ITI Wheelchair, Powered
- 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.
- Root cause tag
- supplier
- FDA 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 in commerce
- 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, France
- Product codes and lots
- All serial numbers between 05A000-05C999.
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