BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1329-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1329-2020
    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 PCF, 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) SN374 SN17081704 SN17121782 SN18011800 SN18081862 SN18061846 SN18111907

    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

    131