Day

January 20, 2021
Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology...
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Company: Philips North America, LLC Date of Enforcement Report: 1/20/2021 Class II PRODUCT Emission Computed Tomography System Image Process System – Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Recall Number: Z-0852-2021 REASON A software defect that has the potential to result in image...
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Company: Medtronic Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000. Recall Number: Z-0843-2021 REASON Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 1/20/2021 Class II PRODUCT Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 – Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy. Recall Number: Z-0860-2021 REASON A710 Intellis Clinician Application has...
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Company: ICU Medical, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT icumedical Cogent” Hemodynamic Monitoring System – Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Recall Number: Z-0859-2021 REASON Due to a potential software issue,...
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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: https://events.eventzilla.net/e/october-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

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