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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Pronto M41 Power Wheelchair

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  Class 2 Device Recall Invacare Pronto M41 Power Wheelchair see related information
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  
Product Classification Invacare Pronto M41 Power Wheelchair - Product Code ITI
Product MK5 NX Controller--Wheelchair controller
Code Information P/N 1143839
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact Invacare Technical Services
440-329-6595
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.
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
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.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.
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