Company:Philips Medical Systems Inc.
Date of Enforcement Report 4/4/12
Class ll:
PRODUCT
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment.
REASON
Incorrect Standardized Uptake Value (“SUV”) values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 08, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
822 units
DISTRIBUTION
Nationwide and Internationally
