BEUDAMED
    FDA Recall Terminated

    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

    Recall: Z-2736-2016 · Initiated May 25, 2016

    Recall

    Recall Number
    Z-2736-2016
    Event Number
    74894
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 25, 2016
    Terminated
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

    Reason

    The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.

    Action

    The firm is informing the consignee of this issue through Customer Information Letter.

    Distribution

    Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

    Quantity

    424 units