BEUDAMED
    FDA Recall Open, Classified

    PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143

    Recall: Z-1507-2024 · Initiated December 24, 2020

    Recall

    Recall Number
    Z-1507-2024
    Event Number
    94229
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 24, 2020
    Posted
    April 9, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143

    Reason

    Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured

    Action

    Philips Healthcare issued Customer Information letter on 12/24/20 via USPS. Letter states reason for recall, health risk and action to take: You may continue to use your system(s) in accordance with the intended use. Refer to ADVICE ACTIONS BY CUSTOMER/USER of the customer letter for specific details regarding the issue descriptions and advice to customers. Should the customer feel uncertain regarding this action, please contact your local Philips representative. Field Change Orders (FCO72800727) involving software upgrade will be released to correct the issue at no charge to you. The planned release date is in Q1 2021. A Philips Field Service Engineer will contact you to schedule the upgrade at your site.

    Distribution

    Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia Myanmar Nepal Netherlands Norway Pakistan Palestine, State of Peru Philippines Poland Puerto Rico Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Spain Sweden Switzerland Thailand Tunisia Turkey United Arab Emirates United Kingdom Uzbekistan Viet Nam

    Quantity

    428 units