BEUDAMED
    FDA Recall Terminated

    Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    Recall: Z-1010-2012 · Initiated January 9, 2012

    Recall

    Recall Number
    Z-1010-2012
    Event Number
    61004
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 9, 2012
    Posted
    February 13, 2012
    Terminated
    October 9, 2012
    Address
    415 Jessen Ln, Charleston, SC, 29492

    Description

    Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    Reason

    The ALC+ function may not be properly locked during use resulting in the possibility of the handle falling off into the surgical field causing injury to the patient.

    Action

    The firm, TRUMPF Medical Systems, Inc., sent an "Urgent Safety Information" notice/package dated January 9, 2012 to its customers. (Note: Some were delivered by TRUMPF representatives in person and some via mail with Urgent Safety identification on the envelope). The notice describes the product, problem and actions to be taken. TRUMPF will replace all sterilizable handles of this type in the field with new handles, in addition, TRUMPF will send new handles and verify disposal of the old version at the customers location. Distribution of new handles will start January 2012. The customers were instructed to ensure that all users and other relevent persons are informed of the Urgent Safety Information; store the information until the measure has been completed and complete and return the Confirmation of User Receipt form via mail to TRUMPF Medical Systems, Inc. 1046 LeGrand Blvd., Charleston, SC 29063 or email: [email protected]. If you have any questions, call 843-822-6939.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MO, NC, NM, NJ, NY, OH, PA, TX, VA, VT, WA, and WI; and countries of: Australia; Austria, Belguim, China, Cyprus, Denmark, Estonia, Finland, France, Germany, Great Britain, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea, Latvia, Luxembourg, Mexico, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Seychelles, Singapore, South Africa (Zuid Afirka), Spain, Sweden, Switzerland (Confederation of Helvetia), Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, and Viet Nam.

    Quantity

    8,733 units