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Terminated

Siemens syngo.plaza radiological image processing system.

FDA Recall Z-0048-2013 · Posted 2012-10-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-06-06
Date Terminated2013-04-13
Product Quantity11

Reason for Recall

Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

Firm Action

The firm initiated this correction on June 6, 2012 by issuing update instructions SY129/12/S to consignees. A script will be distributed to all potential affected customer systems which will prevent data loss by setting the delete protection on all affected studies.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.

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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