BEUDAMED
    FDA Recall Terminated

    Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light.

    Recall: Z-1640-2010 · Initiated April 15, 2010

    Recall

    Recall Number
    Z-1640-2010
    Event Number
    55477
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 15, 2010
    Posted
    May 21, 2010
    Terminated
    January 24, 2011
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251. Intended to illuminate the operative site during surgical procedures with high intensity light.

    Reason

    Installation records are incomplete.

    Action

    An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    608 (all lights and booms)