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

• Date Initiated by Firm: October 11, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on April 12, 2012
• Recall Number: Z-0303-06
• Recall Event ID: 33772
• 510(K)Number: K001777 K993413
• 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: 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