A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
FDA Recall Z-1349-2016 · Posted 2016-04-07
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-18
Date Terminated2017-08-03
Product Quantity49 imaging systems
Reason for Recall
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Firm Action
Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
Root Cause
Software design
Distribution Pattern
US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
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.
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