Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs see related information
Date Initiated by Firm June 26, 2012
Date Posted July 31, 2012
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SUNRISE MEDICAL, INC.
-
-