Pronto Series Power Wheelchair, model M51.
FDA Recall Z-0902-05 · Posted 2005-06-17
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Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2005-05-02
Date Terminated2008-01-04
Product Quantity1418 devices.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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