In the Enforcement Report for the week of January 23 the FDA lists the voluntary Class II Recall by Philips Medical Systems (Cleveland) Inc of the computed tomography x-ray system Brilliance workspace portal, a component of the computed tomography x-ray system that produces 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.
Philips recalled the 108 units when it 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, making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Click here for more details on Recall Number Z-0675-2013.
