BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Spectral CT on Rails. Model Number: 728334.

    Recall: Z-1825-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1825-2026
    Event ID
    98588
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2026
    Initiation Date
    March 7, 2026
    Classification Date
    April 16, 2026
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    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? <Yes> or <No> 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.

    Code Info

    Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007.

    Distribution

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

    Quantity

    3 systems