Cl ll syngo Dynamics

Company: Siemens Medical Solutions, USA, Inc.
Date of Enforcement Report 8/24/11
Class ll:

PRODUCT
syngo Dynamics Picture Archiving Communication System. The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation. Recall # Z-2762-2011

REASON
For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portals, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter on May 10, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
38 units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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