Spectral CT on Rails

• • Ongoing Z-1825-2026 FDA Class II ·initiated 7 Mar 2026

  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.

• • Ongoing Z-1318-2026 FDA Class II ·initiated 7 Jan 2026

  As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

• • Ongoing Z-2034-2025 FDA Class II ·initiated 29 May 2025

  Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

• • Ongoing Z-1324-2025 FDA Class II ·initiated 28 Feb 2025

  Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

• • Ongoing Z-0583-2025 FDA Class II ·initiated 16 Nov 2024

  Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

• • Ongoing Z-1756-2024 FDA Class II ·initiated 29 Mar 2024

  Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.

• 2 recalls, same reason

  • Ongoing Z-1054-2024 FDA Class II ·initiated 13 Dec 2023
  • Ongoing Z-1055-2024 FDA Class II ·initiated 13 Dec 2023

  A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

• • Ongoing Z-0725-2024 FDA Class II ·initiated 30 Nov 2023

  Multiple software issues that affect device functionality.

• • Ongoing Z-0319-2024 FDA Class II ·initiated 9 Oct 2023

  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).

• • Ongoing Z-0306-2024 FDA Class II ·initiated 9 Oct 2023

  When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

• • Ongoing Z-1584-2023 FDA Class II ·initiated 17 Mar 2023

  Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

• • Ongoing Z-1986-2021 FDA Class II ·initiated 1 May 2021

  Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

• • Terminated Z-2318-2021 FDA Class II ·initiated 8 Jun 2021

  When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Generic Name

Full-body CT system

Device Name

Spectral CT on Rails system

Model / Ref / Catalog

728334, Spectral CT on Rails

Primary DI / UDI-DI

00884838103627

Basic UDI-DI

0884838BM996UE

FDA Product Code

JAK

EMDN Code

Z11030601 Computed tomographs - not exceeding 2 layers

GMDN Term

Full-body CT system

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

892.1750

Market of Registration

Netherlands

Commercial Distribution

In Commercial Distribution

EUDAMED SRN

NL-MF-000001489

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

• Ingenia Ambition S

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030 GUDID on market

• Mr 7700

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030 GUDID on market

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