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 Number728144
- Lot codes and dates
- UDI-DIUnique
- Device Identifier Rule{01)00884838105508(21) + Serial number
- Serial Numbers-Applied to FCO72800820
148 of 148 codes
340023400634007340183401934023340253402634031340323403334038340403404134042340473404934050340513405234053340543405534056340573405834059340603406434066340673406834071340723407334074340753407734078340793408034081340823408334085340863408834089340903409134092340933409534097341003410134102341033410534106
- Serial Numbers -Applied to FCO72800820
34337343503434155050334351343583436734368343743438434385
- Amount recalled
- 155 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.
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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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