BEUDAMED
    FDA Enforcement Class II 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 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0405-2013
    Event ID
    63596
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    October 25, 2012
    Classification Date
    November 20, 2012
    Termination Date
    November 20, 2012
    Address
    5160 Hacienda Dr, N/A, Dublin, CA, 94568-7562, United States

    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.

    Code Info

    Part number 304534-7500-001; lot number 540959.

    Distribution

    Nationwide Distribution including IL and MD

    Quantity

    36 total, all lots