November 20, 2019
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/20/2019 Class II PRODUCT Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and...
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Company: Draegar Medical Systems, Inc. Date of Enforcement Report: 11/20/2019 Class II PRODUCT Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 Recall Number: Z-0372-2020 REASON The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. RECALLING FIRM/MANUFACTURER Draegar...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Software risk analysis
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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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