Reported May 31, 2023 · Ongoing
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (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 Power- Whole-body computed tomography (CT)
- X-Ray System Model Number728148 (OUS)
- Lot codes and dates
- UDI-DI(01)00884838103467 (21)
- Serial Number102342065
- Amount recalled
- 1 unit
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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