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Terminated

syngo Dynamics Picture Archiving Communication System The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.

FDA Recall Z-2762-2011 · Posted 2011-07-08

Recalling FirmSiemens Medical Solutions, USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-05-10
Date Terminated2012-07-09
Product Quantity38

Reason for Recall

For systems upgraded to syngo Dynamics version 9.0, if a legacy report generated by version 3.x or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.

Firm Action

Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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