FDA Enforcement
Class II
Terminated
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Recall: Z-2467-2015
·
Reported September 2, 2015
Enforcement
- Recall Number
- Z-2467-2015
- Event ID
- 71829
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Sunrise Medical (US) LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 2, 2015
- Initiation Date
- July 27, 2015
- Classification Date
- August 26, 2015
- Termination Date
- December 10, 2015
- Address
- 2842 N Business Park Ave, N/A, Fresno, CA, 93727-1328, United States
Description
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Reason
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.
Code Info
Model EIZ4-2, serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928.
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Quantity
64 total wheelchairs, both models.