BEUDAMED
    FDA Enforcement Class II Terminated

    Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    Recall: Z-0018-2014 · Reported October 23, 2013

    Enforcement

    Recall Number
    Z-0018-2014
    Event ID
    66000
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Getinge Disinfection
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    October 17, 2013
    Termination Date
    May 11, 2015
    Address
    Ljungadalsgatan 11, Vaxjo, N/A, Sweden

    Description

    Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    Reason

    Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.

    Code Info

    Model # 46-4, Serial # range SEV0521184-SEV0838137

    Distribution

    USA Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and internationally in Canada.

    Quantity

    143 units (142 domestically & 1 unit internationally)