Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Pending LLM rewrite. Source: FDA_DEVICE Z-0881-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Model Number: 728143
- UDI-DI: 00884838085015
- Serial Numbers: 500092
- 500202
- 500309
- 500376
- 500574
- 500265
- 500264
- 510051
- 500034
- 500544
- 500543
- 500548
- 500046
- 500168
- 500064
- 500110
- 500111
- 500102
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22