Company:Philips Medical Systems (Cleveland) Inc.
Date of Enforcement Report 9/26/12
Class lll:
PRODUCT
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.Recall Number Z-2404-2012
REASON
Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., cleveland, OH on 8/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
93 units
DISTRIBUTION
Nationwide and Internationally
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