Day

January 27, 2021
Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001. Recall Number: Z-0883-2021 REASON A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent...
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Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Recall Number: Z-0877-2021 REASON When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is...
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT Synapse PACS Software Versions 5.1 and higher Recall Number: Z-0878-2021 REASON There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies...
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  • 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!

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Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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