Company: Philips Medical Systems, Inc.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The 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
Recall Number Z-0236-2015
REASON
It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA 7/31/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16
DISTRIBUTION
Nationwide
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