December 16, 2020
Company: Canon Medical System, USA, INC. Date of Enforcement Report: 12/16/2020 Class II PRODUCT Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L – Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Recall Number: Z-0549-2021 REASON A software problem has been identified which could result in the...
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Company: Shimadzu Medical Systems Date of Enforcement Report: 12/16/2020 Class II PRODUCT Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support – Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. Recall Number: Z-0554-2021 REASON The firm has identified a problem with...
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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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