Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
FDA Recall Z-2719-2015 · Posted 2015-09-02
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-07-06
Date Terminated2017-01-06
Product Quantity37
Reason for Recall
Potential issue leading to data loss and patient data mix-up
Firm Action
Siemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
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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