Day

September 23, 2015
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/23/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional,...
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Company: Medtronic Inc. Cardiac Rhythm Disease Management Date of Enforcement Report 9/23/2015 Class lI: PRODUCT Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. Recall Number Z-2777-2015 REASON Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended...
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The U.S. FBI issued a Public Service Announcement on the Internet of Things that includes, “Criminals can also gain access to unprotected devices used in home health care, such as those used to collect and transmit personal monitoring data or time-dispense medicines. Once criminals have breached such devices, they have access to any personal or...
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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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