January 12, 2022
Company: Abbott Molecular, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Alinity m System, Part No. 08N53-002 Recall Number: Z-0461-2022 REASON There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. RECALLING FIRM/MANUFACTURER Abbott Molecular, Inc. on 12/6/2021. Voluntary: Firm initiated VOLUME OF PRODUCT...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 Recall Number: Z-0449-2022 REASON (1)Software (SW) versions V1.25.1 and lower may result...
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FDA recently posted the following cybersecurity alert: On Tuesday, December 21, 2021, the Cybersecurity and Infrastructure Security Agency (CISA) published a vulnerability medical advisory ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions as an...
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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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