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October 21, 2022
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 10/21/2022 Class II PRODUCT ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Recall Number: Z-0119-2023 REASON Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

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IEC 81001-5-1 Cybersecurity Lifecycle

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IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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