Reported Dec 24, 2014 · Terminated
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a…
Philips Medical Systems, Inc.
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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Brilliance iCT Computed
- Tomography X-Ray System Product UsageThe Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
- Lot codes and dates
- Software version 4.1.
- Amount recalled
- 16 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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