BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

    Recall: Z-1623-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1623-2023
    Event ID
    92238
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS HEADQUARTERS CAMBRIDGE
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2023
    Initiation Date
    April 12, 2023
    Classification Date
    May 23, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)

    Reason

    Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

    Code Info

    UDI-DI: (01)00884838085015(21) Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378 Serial Numbers: 75592542 81629039 82435668 84375501 85146962 85469672 86188405 86188817 86820074 87367597 92174932 92622328 92637836 92680372 92823844 92870027 92889235 94581069 95050209 95055576 96094114 96462378

    Distribution

    AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

    Quantity

    22 units