Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backres
FDA device recall Z-2467-2015 · posted 2015-08-26 · Terminated
Recall details
- Recalling firm
- Sunrise Medical (US) LLC
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IOR
- Quantity affected
- 64 total wheelchairs, both models.
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
- Date initiated
- 2015-07-27
- Date posted
- 2015-08-26
- Date terminated
- 2015-12-10
- Location
- Fresno, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUICKIE & ZIPPIE SERIES (K123975) | Sunrise Medical | 2013-08-16 |