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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Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact

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