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Terminated

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

FDA Recall Z-2270-2013 · Posted 2013-09-23

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2013-06-04
Date Terminated2016-01-04
Product Quantity166,230

Reason for Recall

Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

Firm Action

Invacare 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

Root Cause

Process control

Distribution Pattern

Worldwide 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, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa.

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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