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
