Day

December 2, 2015
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Syngo Imaging VB36D_HF02. Radiological image processing system. Recall Number Z-0319-2016 REASON To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. RECALLING FIRM/MANUFACTURER...
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Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4. Recall Number Z-0337-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...
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Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3-A. For home hemodialysis. Recall Number Z-0336-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...
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Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler – Model no. NX1000-3. For home hemodialysis. Recall Number Z-0335-2016 REASON Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed RECALLING...
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Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A Recall Number Z-0327-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16...
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Company:.NxStage Medical, Inc.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 Recall Number Z-0326-2016 REASON Ultrafiltration (UF) Volume software error inaccurate fluid removal RECALLING FIRM/MANUFACTURER NxStage Medical, Inc., Lawrence, MA on 10/29/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 323...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Recall Number Z-0325-2016 REASON When a fused series of a sagittal, coronal or radial multi station scan is generated...
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Company:Philips Electronics North America Corporation.Date of Enforcement Report 12/2/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. Recall Number Z-0320-2016 REASON The following MRx software issue has been identified: MRx model M3535A with software version F.03.06...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

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

Instructor: Brian Pate

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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