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Philips Medical Systems (Cleveland) Inc recalls The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intend
Recalled September 26, 2012 · FDA recall Z-2404-2012 · Philips Medical Systems (Cleveland)
Hazard
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. · FDA Class III
Units
93 units
Sold at
Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India.
Description
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.
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →