Day

February 10, 2021
Company: Biomeme, Inc. Date of Enforcement Report: 2/10/2021 Class III PRODUCT Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler...
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Company: Topcon Medical Systems, Inc. Date of Enforcement Report: 2/10/2021 Class II PRODUCT Harmony Referral System (aka Harmony RS)/ Medical Device Data System – Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information. Recall Number: Z-0952-2021 REASON Harmony RS integrations with Topcon equipment,...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 2/10/2021 Class II PRODUCT Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx...
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Company: Community Blood Center of the Ozarks Date of Enforcement Report: 2/10/2021 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0216-2021 REASON Blood products, associated with a blood bank software glitch, were distributed. RECALLING FIRM/MANUFACTURER Community Blood Center of the Ozarks on 9/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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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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