CT 5300

• EUDAMED Basic UDI-DI 0884838BM285T6 registered 26 Jun 2025 Active
• FDA 510(k) K232491 decided 3 May 2024 Active
• FDA GUDID UDI-DI 00884838113237 listed 11 Nov 2024 Listed

• 2 recalls, same reason

  • Ongoing Z-0882-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0881-2026 FDA Class II ·initiated 29 Oct 2025

  If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

• 3 recalls, same reason

  • Ongoing Z-0375-2026 FDA Class II ·initiated 25 Sep 2025
  • Ongoing Z-0377-2026 FDA Class II ·initiated 25 Sep 2025
  • Ongoing Z-0376-2026 FDA Class II ·initiated 25 Sep 2025

  Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

1. 3 May 2024 Cleared FDA 510(k) K232491
2. 11 Nov 2024 Listed FDA GUDID 00884838113237
3. 26 Jun 2025 Registered EUDAMED 0884838BM285T6
4. 25 Sep 2025 Recall initiated FDA recalls Z-0375-2026
5. 25 Sep 2025 Recall initiated FDA recalls Z-0377-2026
6. 25 Sep 2025 Recall initiated FDA recalls Z-0376-2026
7. 29 Oct 2025 Recall initiated FDA recalls Z-0882-2026
8. 29 Oct 2025 Recall initiated FDA recalls Z-0881-2026

Generic name

Full-body CT system

Device name

CT Scanner System (Incisive CT/CT5300)

Model / Ref / Catalog

728285, CT 5300

Primary DI / UDI-DI

00884838113237

Basic UDI-DI

0884838BM285T6

Direct marketing DI

00884838113237

FDA product code

JAK

EMDN code

Z11030606 Computed tomographs - 128 layers or more but less than 256 layers

GMDN term

Full-body CT system

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

892.1750

EU registration type

Standard device

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

EUDAMED SRN

CN-MF-000003923

Authorised representative

Philips Medical Systems Nederland B.V. NL-AR-000001422

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• Arm Support

  Class I

  CE/MDR

• Adjustable Lateral Cassette Holder

  Class I

  CE/MDR

• dS NVS Head Base Coil 1.5T

  Class IIb

  CE/MDR

• DuraDiagnost F30

  Class IIb

  CE/MDR

See all devices from Philips Healthcare (Suzhou) Co., Ltd. →