Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI; 10090334. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
FDA Recall Z-0545-2009 · Posted 2009-01-02
Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-07-23
Date Terminated2010-10-18
Product Quantity306 of all products.
Reason for Recall
If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
Firm Action
Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.