November 11, 2020
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/11/2020 Class II PRODUCT ARTIS Icono Interventional Fluoroscopic X-Ray system – Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number: Z-0400-2021...
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Company: Boston Scientific Corporation Date of Enforcement Report: 11/11/2020 Class II PRODUCT Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Recall Number: Z-0319-2021 REASON There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly...
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At SoftwareCPR today, we honor our consultants that are also veterans who served in our US military! John Murray – US Navy Mike Russell – US Air Force Greg Sandoe – US Marine Corps Jordan Pate – US Army Paul Felten – US Army Thank you for your service!
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Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

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