Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 3/29/2017
Class lI:
PRODUCT
ONCOR” Expression ONCOR” Impression ONCOR” Impression plus
Recall Number Z-1491-2017
REASON
Software updates
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
80 systems
DISTRIBUTION
Nationwide Distribution
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Being Agile & Yet Compliant (Public)
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
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TBD
Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
