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Terminated

syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system

FDA Recall Z-0515-2012 · Posted 2012-01-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-09-19
Date Terminated2014-01-24
Product Quantity12

Reason for Recall

Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series.

Firm Action

Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory letter dated August 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you detect patient data inconsistenceis in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including the states of CA, IN, IA, NV, NE, NY, OH, TN and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082430SYNGO IMAGING XSSiemens AG Medical Solutions · 2008-11-14

Official Source

View FDA Recall →

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

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