Reported May 29, 2024 · Ongoing
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number:…
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 - Computed Tomography X-Ray System intended to produce cross-sectional images of the body
- Model Number728143
- Lot codes and dates
- UDI-DI(01) 00884838085015 (21) + Serial number
- Serial Numbers- Applied to FCO72800819
500046500064500074500102500110500111500145500168500178500211 500216500217500222500225500230500240500242
- Serial Number-Applied to FCO72800820500615
- Amount recalled
- 18 units
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
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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