Day

July 3, 2019
Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/3/2019 Class II PRODUCT PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Recall Number: Z-1892-2019 REASON There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2019 Class II PRODUCT Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored,...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

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