BEUDAMED
    FDA Enforcement Class II Terminated

    Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.

    Recall: Z-2290-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2290-2016
    Event ID
    74596
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunrise Medical (US) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    July 1, 2016
    Classification Date
    July 25, 2016
    Termination Date
    September 11, 2017
    Address
    2842 N Business Park Ave, N/A, Fresno, CA, 93727-1328, United States

    Description

    Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.

    Reason

    There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.

    Code Info

    Model EIR 4 13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394. Serial number range:

    Distribution

    US and Mexico, Japan, Chile, Kuwait, Columbia, Hong Kong, China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles, British Virgin Islands,

    Quantity

    12,142 devices in US, 1,710 devices internationally.