Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2467-2015

July 27, 2015

Class II

Product summary

Firm
Sunrise Medical (US) LLC
Event
Event 71829
Status
Terminated
Classification
Class II
Quantity
64 total wheelchairs, both models.
Official record key
device-enforcement:Z-2467-2015

Official wording

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 information: Model EIZ4-2, serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928.

Distribution pattern: Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.