BEUDAMED
    FDA Enforcement Class II Terminated

    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography

    Recall: Z-0330-2018 · Reported January 17, 2018

    Enforcement

    Recall Number
    Z-0330-2018
    Event ID
    78880
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2018
    Initiation Date
    October 19, 2017
    Classification Date
    January 10, 2018
    Termination Date
    September 20, 2018
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography

    Reason

    The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.

    Code Info

    All CombiDiagnost R90 UDI 709030

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.

    Quantity

    10