Medical device recalls Moderate risk

Sunrise Medical (US) LLC recalls Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backre…

Recall date
July 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2467-2015
FDA classification
Class II
Brand / firm
Sunrise Medical (US) LLC
Sold / distributed
Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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