BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

    Recall: Z-1624-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1624-2023
    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 Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (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)00884838103467 (21) Serial Number: 102342065

    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

    1 unit