Reported Dec 10, 2025 · Ongoing
Incisive CT; 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?
- Incisive CT
- Software Version Number
4.55.05.1
- Lot codes and dates
- 1)
- Model Number728143
- UDI-DI00884838085015
- Serial Numbers
1,101 of 1,101 codes
500092500202500309500376500574500265500264510051500034500544500543500548500046500168500064500110500111500102500145500178500255500217500211500216500225330095002425002525002225002823300550030133001330353303933002330033300733013330473301133008330153302033010330463301733019330493301633024330063302533034330413303833031330423303333037
- Model Number728144
- UDI-DI00884838105508
- Serial numbers
1,241 of 1,241 codes
55207055209434415340105520365501385501335520515503205500765503195501905502305502315503745501263400234006340073402534026340183402334031340333403234038340413404234040340513404734050340493405234053340543405634057340553406034058340593406434066340723406734068340713407434073340783407934075340773408234081340833408534088
- Amount recalled
- 2341 units
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.
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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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