May 31, 2012
Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-1175-2012 REASON An...
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Company:Siemens Healthcare Diagnostics, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension...
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Company:Safe Trace Tx (Horizon Blood Bank, Haemonetics Software SolutionsDate of Enforcement Report 5/30/12 Class ll: PRODUCT SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12 REASON Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO...
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Company:Philips Healthcare Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012 REASON Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling RECALLING FIRM/MANUFACTURER Recalling Firm:...
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Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/30/12 Class ll: PRODUCT ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012 REASON When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the...
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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:


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