BEUDAMED
    FDA Enforcement Class II Terminated

    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128

    Recall: Z-2079-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2079-2012
    Event ID
    61974
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    May 25, 2012
    Classification Date
    July 26, 2012
    Termination Date
    May 18, 2016
    Address
    1777 E Henrietta Rd, Rochester, NY, 14623-3133, United States

    Description

    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128

    Reason

    Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.

    Code Info

    Serial numbers: W50024258; W50024259; W50026573; W50025790; W50017381; W50020296; W50028138; W50020952

    Distribution

    Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada

    Quantity

    8 washers