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Terminated

syngo.plaza Image processing system

FDA Recall Z-0522-2012 · Posted 2012-01-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-09-21
Date Terminated2014-01-31
Product Quantity1

Reason for Recall

Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.

Firm Action

Siemens Medical Solutions USA sent a Customer Safety Advisory Notice dated March 10, 2011 to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the customer of the potential issues and provides additional information on the implemented resolution. For further questions please call (610) 219-4834.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution New York

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093612SYNGO.PLAZASiemens AG Medical Solutions · 2010-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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