Recall Z-2467-2015— Sunrise Medical (US) LLC
Class II · Terminated
Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2015-07-27, terminated 2015-12-10. It names one FDA 510(k) clearance: K123975. Product: 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..
- Recalling firm
- Sunrise Medical (US) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-27
- Terminated
- 2015-12-10
- Firm location
- Fresno, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.