In the Enforcement Report for the week of January 2, 2013, the FDA listed the Class II recall of the Extended Brilliance workspace (EBW) in order to update the system.
Philips issued a Field Change Order to update the EBW systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues, which will improve the overall quality and functionality of the EBW.
The EBW 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 company distributed 265 units in the US and in Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea, and in the United Kingdom.
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