BEUDAMED
    FDA Recall Open, Classified

    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF

    Recall: Z-1308-2022 · Initiated May 6, 2022

    Recall

    Recall Number
    Z-1308-2022
    Event Number
    90305
    Firm
    Getinge Usa Sales Inc
    FEI Number
    3013876692
    Product Code
    FSY
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 6, 2022
    Posted
    June 30, 2022
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035

    Description

    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF

    Reason

    Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

    Action

    On May 6, 2022, the firm notified affected customers through an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily inspections per the IFU, which include checking for any chipped or missing paint. If you observe paint chipping or detachment, the firm recommends that you stop using the device and contact your Getinge service representative to schedule an appointment to replace the part free of charge. The firm is requesting that customers contact their Getinge service representative to have the part replaced if chipped or missing paint is observed through April 2025. Getinge service representatives will inspect the affected component during periodic maintenance and will replace the component if the issue is observed through April 2025.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.

    Quantity

    337 (US); 8594 (OUS)