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Class 2 Device Recall 3G Storm Series Power Wheelchair with Power Tilt Option. |
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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
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Product Classification |
Wheelchair, Powered - Product Code ITI
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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
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For Additional Information Contact |
Janice K. Brownlee 440-329-6000
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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.
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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
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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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