Day

December 30, 2015
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Recall Number Z-0550-2016 REASON For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction...
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Company: Shimadzu Medical Systems.Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Mobile X-ray system MobileDaRt Evolution/FDR Go Software Recall Number Z-0451-2016 REASON Shimadzu Corporation is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly… RECALLING FIRM/MANUFACTURER Shimadzu Medical Systems, Torrence, CA on 11/10/2015. Voluntary: Firm Initiated recall is...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity CT Computed Tomography X-ray system Recall Number Z-0549-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT SP Computed Tomography X-ray system Recall Number Z-0546-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance iCT Computed Tomography X-ray system Recall Number Z-0545-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray system Recall Number Z-0544-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray system Recall Number Z-0547-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Ingenuity Core 128 Computed Tomography X-ray system Recall Number Z-0548-2016 REASON Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...
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Company: Draeger Medical, Inc. Date of Enforcement Report 12/30/2015 Class lI: PRODUCT Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Recall Number Z-0436-2016 REASON The firm became aware of cases in which the battery...
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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)

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