BEUDAMED
    FDA Recall Open, Classified

    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

    Recall: Z-0319-2024 · Initiated October 9, 2023

    Recall

    Recall Number
    Z-0319-2024
    Event Number
    93362
    Firm
    Philips North America
    FEI Number
    3006648320
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 9, 2023
    Posted
    November 16, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296

    Description

    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

    Reason

    This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

    Action

    An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Below are short-term precautions to take until the permanent solution is installed. Remain vigilant and confirm gantry position during procedures. Review the Emergency Stop Procedure and Collision Prevention Guidelines provided in Section 6: Working with Specialized Exams of the IFU. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update (FCO 72800805) to resolve the issue. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

    Distribution

    US Nationwide distribution in the state of MN.

    Quantity

    1 unit