MK5 NX Controller--Wheelchair controller
FDA device recall Z-2091-2014 · posted 2014-07-22 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- 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.
- Action taken
- 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 cscomplaints@invacare.com
- Root cause
- Process control
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 819
- Distribution
- 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.
- Date initiated
- 2014-06-24
- Date posted
- 2014-07-22
- Date terminated
- 2014-10-15
- Location
- Elyria, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 (K021680) | Invacare Corp. | 2002-06-18 |