November 10, 2021
Company: FujiFilm Healthcare Americas Corporation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Recall Number: Z-0189-2022 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Recall Number: Z-0190-2022 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Recall Number: Z-0191-2022 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 Recall...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/10/2021 Class II PRODUCT Artis zeego, Fluoroscopic X-Ray System: Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 Recall Number: Z-0200-2022 REASON Software error,...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Clinician Programmer Application (CPA) model A610 Clinician Software Application Recall Number: Z-0201-2022 REASON A software anomaly may occur with the clinician programmer application. RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation on 9/23/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 3302 DISTRIBUTION U.S. Nationwide...
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Upcoming SoftwareCPR Training Courses:

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.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

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


Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:


Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.