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Recall Observatory FDA recall evidence

Device product

MK5 NX Controller--Wheelchair controller

Z-2091-2014

June 24, 2014

Class II

Product summary

Firm
Invacare Corporation
Event
Event 68622
Status
Terminated
Classification
Class II
Quantity
819
Official record key
device-enforcement:Z-2091-2014

Official wording

Reason: M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.

Code information: P/N 1143839

Distribution pattern: Nationwide Distriution: CA, SC, IL, UT, TN, KS, HI, NJ, LA, TX,FL, IN, AL, AZ, MN, WI, MN, MI, AR,MA, GA, MS, NJ, NM, OK, ME, PA, NY, NC, OK, MO, WA, IA, OR,KY, MD, NE, ID, VA, WA, ND, MT, OH, NH, CT. Also shipped to Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.