BEUDAMED
    FDA Recall Open, Classified

    Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

    Recall: Z-2261-2023 · Initiated April 25, 2023

    Recall

    Recall Number
    Z-2261-2023
    Event Number
    92202
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 25, 2023
    Posted
    July 28, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

    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

    Action

    Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23 International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800798). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

    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

    6 units OUS