Day

February 3, 2010
On February 20, 2003, a final security rule 45 CFR Part 142 was issued. Subsequently HHS issued a series of educational documents regarding various aspects of the rule including administrative controls, physical controls, technical safeguards, risk management and others.  
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Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010; 2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010 REASON A software defect – may result in a false indication and...
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Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0600-2010; 2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1....
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Company:GE Medical SystemsDate of Enforcement Report 2/3/2010 Class:ll PRODUCT GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages...
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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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