BEUDAMED
    FDA Enforcement Class II Ongoing

    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    Recall: Z-1328-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1328-2020
    Event ID
    84773
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Medical Systems Gmbh, DMC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    December 19, 2019
    Classification Date
    February 20, 2020
    Termination Date
    June 18, 2020
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, N/A, Germany

    Description

    CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    Reason

    When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.

    Code Info

    (domestic only) SN18061848 SN17071689 SN18051832 SN190251 SN17111759 SN17111752 SN18011793 10000020 SN17121783 SN17121785 SN18021816 SN18101890 SN19031950 SN17071688 SN18101903 SN17071683 SN17101722 SN17101729 SN17111758 SN17111763 SN17031622 SN17071692 SN17041642 SN18101886 SN18011794 SN19021934 SN19021943 SN17111770 SN18011802 SN19021942 SN17121779 SN17031618 SN17101733 SN17021613 SN17021613

    Distribution

    Worldwide distribution  US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NC, NJ, NY, OH, TX, UT, VA and countries of Canada, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, China, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Egypt, Ethiopia, France, Germany, Ghana, Hungary, Iran, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Martinique, Mexico, Nepal, Netherlands, New Zealand, Nigeria, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

    Quantity

    116