Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
FDA Recall Z-2794-2016 · Posted 2016-09-14
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-08-02
Date Terminated2017-03-20
Product Quantity101 Systems
Reason for Recall
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
Firm Action
Siemens mailed to customers on August 04, 2016 a Customer Advisory Notice that provided interpretations about the meaning of measurement values like area, distance and perimeter shown as "o.p." by the syngo.plaza.
Root Cause
Error in labeling
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.
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