Class 2 Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs

• Date Initiated by Firm: June 26, 2012
• Date Posted: July 31, 2012
• Recall Status: Terminated on November 01, 2012
• Recall Number: Z-2113-2012
• Recall Event ID: 62493
• 510(K)Number: K973673
• Product Classification: Wheelchair, mechanical - Product Code IOR
• Product: Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
• Code Information: Receiver Product number 109207.
• Recalling Firm/ Manufacturer: Sunrise Medical (US) LLC; 2842 N Business Park Ave; Fresno CA 93727-1328
• For Additional Information Contact: Laurie H. Roberts, RAC; 559-294-2395
• Manufacturer Reason for Recall: Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
• FDA Determined Cause: Labeling design
• Action: Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.
• Quantity in Commerce: 14, 035
• Distribution: Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
• 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 = IOR