syngo Imaging, picture archiving and communications system. Model number 7502029
FDA Recall Z-0070-2007 · Posted 2006-10-25
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-09-05
Date Terminated2008-09-17
Product Quantity1818 units total, for all three products
Reason for Recall
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
Firm Action
The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.
Root Cause
Other
Distribution Pattern
The product was shipped to medical facilities nationwide.
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.