PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: September 26, 2012 Initiated: August 28, 2012 #Z-2404-2012

Product Description

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.

Reason for Recall

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.

Details

Units Affected
93 units
Distribution
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.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 93 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 26, 2012. Severity: Low. Recall number: Z-2404-2012.