Z-2466-2015 Class II Terminated
FDA device recall Z-2466-2015 was initiated by Sunrise Medical (US) LLC on July 27, 2015 and is designated Class II. 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. The recall status is terminated (terminated December 10, 2015). Affected quantity: 64 total wheelchairs, both models.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- July 27, 2015
- Termination Date
- December 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 total wheelchairs, both models
Product Description
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.
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 Pattern
Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Code Information
Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.