BEUDAMED
    FDA Recall Terminated

    Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.

    Recall: Z-1380-2018 · Initiated March 2, 2018

    Recall

    Recall Number
    Z-1380-2018
    Event Number
    79641
    Firm
    Getinge Disinfection Ab Ljungadalsgatan
    FEI Number
    3000231474
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 2, 2018
    Terminated
    May 13, 2022
    Address
    11 Vaxjo Sweden

    Description

    Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.

    Reason

    There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

    Action

    A letter (Urgent Medical Device Recall Notice) was issued March 2, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if device is still in use at the facility. The letter instructs the customer to contact Getinge Service to schedule a visit and service by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and perform the correction when affected installed devices are identified. Recalled product will be corrected by a trained Getinge Service Representative. The correction will involve a software update to remove any risk to operators. Additionally a preventive hardware update that provides a longer wearing end stop pin will be performed during the field correction. For further questions please call (585) 214-6049.

    Distribution

    Worldwide Distribution - USA (nationwide) and the following countries: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, NETHERLANDS, NORWAY, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NORWAY, NEW ZELAND, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVENIA, THAILAND

    Quantity

    170 total products