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U.S. Department of Health and Human Services

Class 2 Device Recall 3G Storm Series Power Wheelchair with Power Tilt Option.

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  Class 2 Device Recall 3G Storm Series Power Wheelchair with Power Tilt Option. see related information
Date Initiated by Firm October 11, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-0303-06
Recall Event ID 33772
510(K)Number K993413  K001777  
Product Classification Wheelchair, Powered - Product Code ITI
Product 3G Storm Series Power Wheelchair with Power Tilt Option.
Code Information Serial numbers: 05G066858, 05G066859, 05G071801, 05G071803, 05G077773, 05G079666, 05G089011, 05G089012, 05G092274, 05G105434, 05G106984, 05G111332, 05G117359, 05G121857, 05G125563, 05H144898
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44036-2028
For Additional Information Contact Janice K. Brownlee
440-329-6000
Manufacturer Reason
for Recall		 When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
FDA Determined
Cause 2		 Other
Action The recalling firm sent letters to all consignees.
Quantity in Commerce 16 devices
Distribution The product was sent to distributors located in AL, GA, CA, IL, KS, MN, NC, PA, TX, and VA.
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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