Day

July 8, 2025
Company: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Date of Enforcement Report: 7/8/2025 Class: II PRODUCT Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system Recall Number: Z-2097-2025 REASON: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed....
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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