BEUDAMED
    FDA Recall 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 · Initiated July 27, 2015

    Recall

    Recall Number
    Z-2467-2015
    Event Number
    71829
    Firm
    Sunrise Medical (US) LLC
    FEI Number
    2937137
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 27, 2015
    Posted
    August 26, 2015
    Terminated
    December 10, 2015
    Address
    2842 N Business Park Ave, Fresno, CA, 93727-1328

    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.

    Action

    Sunrise Medical sent an Urgent Medical Device Field Correction letter dated July 27, 2015, to all affected dealers. The letter identified the product, the problem, and the action to be taken by the dealer. Dealers were instructed to immediately contact their customers to make arrangements to have the correction made with a replacement kit which will be supplied by Sunrise Medical to each dealer. Each dealer is requested to send back to Sunrise Medical the Acknowledgment and Response Form(s) by fax, email or regular mail once the work is completed. Customers with questions were instructed to contact Sunrise Medical Regulatory Affairs at (888) 208-4901.

    Distribution

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

    Quantity

    64 total wheelchairs, both models.