Company: Philips Medical Systems (Cleveland) Inc .
Date of Enforcement Report 1/23/2013
Class ll:
PRODUCT
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a 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. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Recall Number Z-0675-2013
REASON
Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH 9/11/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
108 units
DISTRIBUTION
Nationwide and Internationally
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