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.
- Company
- Sunrise Medical (Us) Llc
- Recall Initiated
- July 27, 2015
- Posted
- August 26, 2015
- Terminated
- December 10, 2015
- Recall Number
- Z-2466-2015
- Quantity
- 64 total wheelchairs, both models
- Firm Location
- Fresno, CA
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.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Lot / Code Info
Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.
Root Cause
Device Design
Action Taken
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.