BEUDAMED
    FDA Recall 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 · Initiated October 19, 2017

    Recall

    Recall Number
    Z-0330-2018
    Event Number
    78880
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 19, 2017
    Terminated
    September 20, 2018
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    Philips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000.

    Distribution

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

    Quantity

    10