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U.S. Department of Health and Human Services

Class 2 Device Recall Pronto Series Power Wheelchair.

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  Class 2 Device Recall Pronto Series Power Wheelchair. see related information
Date Initiated by Firm May 02, 2005
Date Posted June 17, 2005
Recall Status1 Terminated 3 on January 04, 2008
Recall Number Z-0901-05
Recall Event ID 32009
510(K)Number K021680  
Product Classification Wheelchair, Powered - Product Code ITI
Product Pronto Series Power Wheelchair, model M50.
Code Information All serial numbers between 05A000-05C999.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44036-2028
For Additional Information Contact Janice K. Brownlee
800-333-6900
Manufacturer Reason
for Recall		 If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
FDA Determined
Cause 2		 Other
Action The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.
Quantity in Commerce 1 device.
Distribution The product was sent to consignees located in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. There was one foreign consignee in France: Poirer, Zac Papillon, 3720 Parcay Meslay, Corps, France
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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