May 5, 2021
Company: Philips North America LLC Date of Enforcement Report: 5/5/2021 Class II PRODUCT Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices – intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with the following: FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/5/2021 Class II PRODUCT Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 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...
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Company: Change Healthcare Canada Company Date of Enforcement Report: 5/5/2021 Class II PRODUCT Change Healthcare Enterprise Viewer Recall Number: Z-1508-2021 REASON Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. RECALLING FIRM/MANUFACTURER Change Healthcare Canada Company on 3/17/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF...
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Company: Datascope Corp. Date of Enforcement Report: 5/5/2021 Class III PRODUCT Cardiosave Hybrid IABP – Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 Recall Number: Z-1506-2021 REASON There are cybersecurity...
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Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here:


Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • 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.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

Register here:–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


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