BEUDAMED
    FDA Recall Open, Classified

    Philips Spectral CT on Rails. Model Number: 728334.

    Recall: Z-1825-2026 · Initiated March 7, 2026

    Recall

    Recall Number
    Z-1825-2026
    Event Number
    98588
    Firm
    PHILIPS MEDICAL SYSTEMS
    FEI Number
    3017726341
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 7, 2026
    Posted
    April 16, 2026
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Spectral CT on Rails. Model Number: 728334.

    Reason

    Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

    Action

    Philips Medical notified consignees on about 03/07/2026 via letter. Consignees were instructed to identify any affected systems in inventory and specifically for each issue: 1. Issue #1: Ensure to follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation. 2. Issue #2: Avoid the Select Previous Surview Unavailable issue, manually remove the patient's middle name while importing the patient detail from HIS/RIS. 3. Issue #3: if Define Head Area option is grayed out with DoseRight Index (DRI) on, review the dose levels displayed on the User Interface, confirm and adjust the dose settings to appropriate levels before executing the scan as instructed in the IFU. Consignees were also instructed to complete and return the response form, to circulate the Urgent Medical Device Correction Letter to all users of the affected device so that they are aware of the issues, and retain the letter with affected system(s) until a solution is installed on each system; ensure the letter is in a place likely to be seen/viewed. Philips will contact each consignee to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and install the solution to resolve the issues (reference FCO72800830).

    Distribution

    Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

    Quantity

    3 systems