ClearanceBrief
Recall Z-2270-2013 ยท ITI Wheelchair, Powered

Invacare Corporation

Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

DateSep 23, 2013 (initiated Jun 4, 2013)
StatusTerminated
ReasonUnintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Root causeProcess control
ActionInvacare sent an Urgent Patient Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their wheelchair povider to have their joystick replaced. Customers with questions were instructed to call their provider at Invacare's recall support line at 877-413-6008. Go to www.invacare.com/joystickrecall for more information regarding this recall
Quantity166,230
DistributionWorldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. Internationally to Canada, Australia, Bermuda, Brazi
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K023589STORM TDX POWER WHEELCHAIR
Invacare Corp., Nov 19, 2002
K993413STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
Invacare Corp., Dec 15, 1999