Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0901-05

Pronto Series Power Wheelchair, model M50

Invacare GmbH / initiated 2005-05-02 / Terminated / root cause: supplier

Invacare Corporation began a recall of Pronto Series Power Wheelchair, model M50 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-0901-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Pronto Series Power Wheelchair, model M50.
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
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
Product codes and lots
All serial numbers between 05A000-05C999.