BEUDAMED
    FDA Recall Terminated

    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    Recall: Z-2419-2015 · Initiated June 26, 2015

    Recall

    Recall Number
    Z-2419-2015
    Event Number
    71777
    Firm
    Getinge Disinfection Ab Ljungadalsgatan
    FEI Number
    3000231474
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    June 26, 2015
    Posted
    August 25, 2015
    Terminated
    May 23, 2018
    Address
    11 Vaxjo Sweden

    Description

    Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

    Reason

    Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

    Action

    Getinge Disinfection AB has initiated a Field Correction due to unauthenticated remote access to the product over the network.

    Distribution

    Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.

    Quantity

    20 devices