Class 2 Device Recall Quickie Rhythm Power Wheelchair

• Date Initiated by Firm: January 11, 2008
• Date Posted: August 23, 2008
• Recall Status: Terminated on November 16, 2009
• Recall Number: Z-1531-2008
• Recall Event ID: 46908
• 510(K)Number: K060531
• Product Classification: Powered Wheelchair - Product Code ITI
• Product: Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10
• Code Information: All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.
• Recalling Firm/ Manufacturer: Sunrise Medical Inc; 2842 N Business Park Ave; Fresno CA 93727-1328
• For Additional Information Contact: 559-292-2171
• Manufacturer Reason for Recall: Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
• FDA Determined Cause: Software design
• Action: Initial phone contact began on January 11, 2008. Medical device correction letters were also sent to affected dealers.
• Quantity in Commerce: 141 units total
• Distribution: Product was distributed to 126 retailers nationwide throughout the USA, as well as Canada and Australia.
• 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