Reported May 31, 2023 · Ongoing

Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (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 Plus -Whole-body computed tomography (CT)
  • X-Ray System Model Number728149 (OUS)
Lot codes and dates
  • UDI-DI(01)00884838103474(21)
  • Serial Number530537 554032 554060 554065 554078
Amount recalled
5 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.