Reported May 31, 2023 · Ongoing
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Philips Headquarters Cambridge
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 HEADQUARTERS CAMBRIDGE · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Incisive CT- Whole-body computed tomography (CT)
- X-Ray System Model Number728143 (OUS)
- Lot codes and dates
- UDI-DI(01)00884838085015(21)
- Serial Numbers
75592542816290398243566884375501851469628546967286188405861888178682007487367597921749329262232892637836926803729282384492870027928892359458106995050209950555769609411496462378
- Serial Numbers
75592542816290398243566884375501851469628546967286188405861888178682007487367597921749329262232892637836926803729282384492870027928892359458106995050209950555769609411496462378
- Amount recalled
- 22 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
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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