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Terminated

syngo Imaging XS, all versions Radiological image processing system

FDA Recall Z-0514-2012 · Posted 2012-01-11

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-09-20
Date Terminated2014-03-05
Product Quantity38

Reason for Recall

Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.

Firm Action

Siemens Medical Solutions USA, Inc sent a Customer Safety Advisory Notice letter dated August 3, 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 inconsistencies in your system caused by this problem, please contact Siemens Service for support. For further questions please call (610) 219-4834.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution including the states of CA, FL, GA, IN, IA, KS, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.

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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