Day

April 6, 2022
06
Apr

Recall – Retinal analysis system software lacks market approval

April 6, 2022
Company: Diagnos Inc. Date of Enforcement Report: 4/6/2022 Class II PRODUCT CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall Number: Z-0826-2022 REASON Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. RECALLING FIRM/MANUFACTURER Diagnos Inc....
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06
Apr

Recall – Unreleased infusion pump software installed

April 6, 2022
Company: InfuTronix LLC Date of Enforcement Report: 4/6/2022 Class II PRODUCT Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Recall Number: Z-0832-2022 REASON An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety...
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06
Apr

Recall – Radiographic system processes incorrect position values

April 6, 2022
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/6/2022 Class II PRODUCT Ysio system with VC10 software version, Model Number 10281013. Radiographic system Recall Number: Z-0841-2022 REASON Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for...
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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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