BEUDAMED
    FDA Enforcement Class II Terminated

    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

    Recall: Z-0001-2018 · Reported October 11, 2017

    Enforcement

    Recall Number
    Z-0001-2018
    Event ID
    78082
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carl Zeiss Meditec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2017
    Initiation Date
    August 30, 2017
    Classification Date
    October 2, 2017
    Termination Date
    January 24, 2018
    Address
    Rudolf-Eber-Str. 11, N/A, Oberkochen, N/A, N/A, Germany

    Description

    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

    Reason

    The device had an incorrect printed calibration value on the calibration certificate.

    Code Info

    Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.

    Distribution

    Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.

    Quantity

    9 devices