Reported Dec 10, 2025 · Ongoing
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- CT 5300
- Software Version Number
4.55.05.1
- Lot codes and dates
- 1)
- Model Number728285
- UDI-DI00884838113237
- Serial Numbers
35071800007800002800001800004800003
- Amount recalled
- 6 units (OUS only)
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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