BEUDAMED
    FDA Enforcement Class II Terminated

    Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.

    Recall: Z-1807-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1807-2013
    Event ID
    65401
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Etac Supply Center Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    May 23, 2013
    Classification Date
    July 25, 2013
    Termination Date
    October 24, 2014
    Address
    Langgatan 12, N/A, Anderstorp, N/A, N/A, Sweden

    Description

    Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.

    Reason

    Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.

    Code Info

    Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)

    Distribution

    International distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates.

    Quantity

    7200 internationally