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Class 2 Device Recall Invacare Pronto M41 Power Wheelchair |
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Date Initiated by Firm |
June 24, 2014 |
Date Posted |
July 22, 2014 |
Recall Status1 |
Terminated 3 on October 15, 2014 |
Recall Number |
Z-2091-2014 |
Recall Event ID |
68622 |
510(K)Number |
K021680
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Product Classification |
Invacare Pronto M41 Power Wheelchair - Product Code ITI
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Product |
MK5 NX Controller--Wheelchair controller |
Code Information |
P/N 1143839 |
Recalling Firm/ Manufacturer |
Invacare Corporation 1200 Taylor St Elyria OH 44035-6248
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For Additional Information Contact |
Invacare Technical Services 440-329-6595
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Manufacturer 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.
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FDA Determined Cause 2 |
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 cscomplaints@invacare.com |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.
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