May 15, 2019
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/15/2019 Class II PRODUCT Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019 Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019 Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019 REASON There were multiple issues identified in the system software which required...
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Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...
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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.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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15148 Springview St
Tampa, FL 33624
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