BEUDAMED
    FDA Recall Terminated

    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

    Recall: Z-0405-2013 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0405-2013
    Event Number
    63596
    Firm
    Carl Zeiss Meditec, Inc.
    FEI Number
    2918630
    Product Code
    JAD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 25, 2012
    Posted
    November 20, 2012
    Terminated
    November 20, 2012
    Address
    5160 Hacienda Dr, Dublin, CA, 94568-7562

    Description

    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.

    Reason

    A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.

    Action

    Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at [email protected]. For questions regarding this recall call 925-557-4616.

    Distribution

    Nationwide Distribution including IL and MD

    Quantity

    36 total, all lots