BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1328-2020 · Initiated December 19, 2019

    Recall

    Recall Number
    Z-1328-2020
    Event Number
    84773
    Firm
    Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany
    FEI Number
    3003768251
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 19, 2019
    Posted
    February 20, 2020
    Terminated
    June 18, 2020

    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.

    Action

    On December 19, 2019, the firm initiated mailing of the Medical Device Recall Letter to all affected customers. Customers were advised to use the system according to the Instructions for Use (IFU). In particular: Error 80 issue: The issue can be prevented if the operator avoids tilting the table by Table Up/Down joystick and instead uses the Table Tilt Left/Right joystick. If the issue occurs, the operator should remove the patient from the table and bring him/her to upright position so that the contrast agent does not enter the brain. SPDU issue: The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately engage the system emergency stop button on the table or geometry control console, remove patient, stop using the system for further examinations and contact customer service. Philips plans to install a system software version upgrade and to perform an on-site check of the SPDU thermos contact at affected systems, which will eliminate these issues. A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented. Should you need to communicate with Philips with regard to this program, please reference Field Change Order (FCO) 70900045 if you have a CombiDiagnost GCF system and FCO 70900048 if you have a CombiDiagnost PCF system. Technical Support Line: 1-800-722-9377.

    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