Atlas FDA

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

FDA device recall Z-2270-2013 · posted 2013-09-23 · Terminated

Recall details

Recalling firm
Invacare Corporation
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.
Action taken
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
Status
Terminated
Product code
ITI
Quantity affected
166,230
Distribution
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, S
Date initiated
2013-06-04
Date posted
2013-09-23
Date terminated
2016-01-04
Location
Elyria, OH

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
STORM TDX POWER WHEELCHAIR (K023589)Invacare Corp.2002-11-19
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL (K993413)Invacare Corp.1999-12-15