510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Z-2091-2014Class II

MK5 NX Controller--Wheelchair controller

Invacare GmbH / initiated 2014-06-24 / Terminated / root cause: manufacturing process

Invacare Corporation began a recall of MK5 NX Controller--Wheelchair controller on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2091-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
MK5 NX Controller--Wheelchair controller
Product code
ITI Wheelchair, Powered
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.
Root cause tag
manufacturing process
FDA root cause
Process control
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]
Quantity in commerce
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. Also shipped to Canada
Product codes and lots
P/N 1143839

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2091-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2091-2014Class IITerminatedVoluntary: Firm initiated