Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an...Read More

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...Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/23/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 – Model #728231; and Ingenuity CT – Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended...Read More