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Terminated

MK5 NX Controller--Wheelchair controller

FDA Recall Z-2091-2014 · Posted 2014-07-22

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2014-06-24
Date Terminated2014-10-15
Product Quantity819

Reason for Recall

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.

Firm Action

The controllers will be reporogrammed in the field upon installation Invacare Sent out a Technical Services Bulletin (Oct. 15, 2012) . Please call 800-832-4707, Monday-Friday, 8:00 am- 7:00 pm EST, for assistance. If you are aware of a consumer complaint regarding this controller, please contact the Invacare Customer Service Complaints Department at 877-374-8919, Monday-Friday, 8:00am- 7:00pm or [email protected]

Root Cause

Process control

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021680INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91Invacare Corp. · 2002-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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