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U.S. Department of Health and Human Services

Class 2 Device Recall Zippie IRIS Wheelchair

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  Class 2 Device Recall Zippie IRIS Wheelchair see related information
Date Initiated by Firm July 27, 2015
Date Posted August 26, 2015
Recall Status1 Terminated 3 on December 10, 2015
Recall Number Z-2466-2015
Recall Event ID 71829
510(K)Number K123975  
Product Classification Wheelchair, mechanical - Product Code IOR
Product Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option.
Provide mobility to persons limited to a sitting position.
Code Information Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.
Recalling Firm/
Manufacturer		 Sunrise Medical (US) LLC
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact Laurie H. Roberts, M.S. RAC
559-348-2572
Manufacturer Reason
for Recall		 Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
FDA Determined
Cause 2		 Device Design
Action Sunrise Medical sent an Urgent Medical Device Field Correction letter dated July 27, 2015, to all affected dealers. The letter identified the product, the problem, and the action to be taken by the dealer. Dealers were instructed to immediately contact their customers to make arrangements to have the correction made with a replacement kit which will be supplied by Sunrise Medical to each dealer. Each dealer is requested to send back to Sunrise Medical the Acknowledgment and Response Form(s) by fax, email or regular mail once the work is completed. Customers with questions were instructed to contact Sunrise Medical Regulatory Affairs at (888) 208-4901.
Quantity in Commerce 64 total wheelchairs, both models
Distribution Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
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
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