Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. Recall Number Z-0907-2013 REASON Siemens...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (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...Read More

Company:Philips Healthcare Inc Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Philips Digital Diagnost Stationary radiographic system. Recall Number Z-0900-2013 REASON When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/13/2013 Class ll: PRODUCT GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional structures imaged with...Read More

Company:Beckman Coulter Inc. Date of Enforcement Report 3/13/2013 Class ll: PRODUCT Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. Recall Number Z-0913-2013 REASON Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration...Read More

Company:Steris Corporation Date of Enforcement Report 3/13/2013 Class ll: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-0915-2013 REASON The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during...Read More