Recall Z-2466-2015
Sunrise Medical (US) LLC · initiated July 27, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.
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: 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.
Details
- Recall number
- Z-2466-2015
- Initiated
- July 27, 2015
- Posted by FDA
- August 26, 2015
- Terminated
- December 10, 2015
- Product code
- IOR – Wheelchair, Mechanical
- Quantity
- 64 total wheelchairs, both models
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
- Recalling firm
- Sunrise Medical (US) LLC, Fresno, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2467-2015 Class II | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO…Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may… | 07/27/2015Terminated |