Reported Jun 9, 2021 · Terminated

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model…

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?

  • BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body
  • Model Number728306
Lot codes and dates
  • Serial Numbers
    • 100100
    • 100434
Amount recalled
2 units (1 US and 1 OUS)

Where it was sold

  • Nationwide
  • NV

Why it was recalled

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 23, 2022 · Data as of Sep 19, 5:41 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.