BEUDAMED
    FDA Enforcement Class II Terminated

    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

    Recall: Z-0612-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0612-2019
    Event ID
    81706
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Gmbh, DMC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2019
    Initiation Date
    November 7, 2018
    Classification Date
    February 12, 2019
    Termination Date
    September 2, 2020
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, N/A, N/A, Germany

    Description

    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System

    Reason

    kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.

    Code Info

    All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, CA, GA, IL, MN, MO, MT, NJ, OH, TX, UT & VA; and to countries of: Australia, Austria, Bangladesh, Belgium, Chile C¿te D'Ivoire, Czech Republic. Egypt, Ethiopia, France, Germany, Ghana, Iran, Italy, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Philippines, Portugal Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    146