BEUDAMED
    FDA Enforcement Class II Ongoing

    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

    Recall: Z-2259-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2259-2023
    Event ID
    92202
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2023
    Initiation Date
    April 25, 2023
    Classification Date
    July 28, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

    Reason

    Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

    Code Info

    UDI-DI: (01)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 540007 540001 540011 540000 540014 540013 540018 540010 540002

    Distribution

    Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam

    Quantity

    20 units OUS