Official recall record
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-10-29
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838085015
- Brand on record
- Philips North America Llc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 5 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2023-04-12 · US FDA — Medical Devices
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS) - 2025-09-25 · US FDA — Medical Devices
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X; - 2023-03-20 · US FDA — Medical Devices
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813 - 2022-12-23 · US FDA — Medical Devices
Incisive CT, model 728143 & 728144 running Software Version 5.0.0. - 2026-06-26 · US FDA — Medical Devices
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Other recalls from this brand
All 58 official recall notices naming Philips North America on this site →