June 9, 2021
The Food & Drug Administration (FDA) has issued a response to NIST to the Executive Order (EO) on Improving the Cybersecurity of the Federal Government (EO 14028), dated 26 May 2021. The document, Response to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain Security, summarizes “established FDA practices...
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Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 6/9/2021 Class II PRODUCT Change Healthcare Enterprise Viewer – Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Recall Number: Z-1773-2021 REASON A software defect was identified where the Image...
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Company: Draeger Medical, Inc. Date of Enforcement Report: 6/9/2021 Class II PRODUCT Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 – Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Recall Number: Z-1690-2021 REASON Three separate and unrelated problems attributed to the software used in the...
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Company: Medtronic Date of Enforcement Report: 6/9/2021 Class II PRODUCT Multiple MiniMed 780G Insulin Pump Models Recall Number: Z-1771-2021 REASON Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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