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Terminated

syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system

FDA Recall Z-1266-2009 · Posted 2009-04-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-02-09
Date Terminated2009-09-23
Product Quantity20 units

Reason for Recall

An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).

Firm Action

A Customer Safety Advisory Notice, dated 02/09/2009 was sent to affected customers via Update Instruction IM013/09S. The letter informs customers of when the malfunction occurs and the potential issue, provides instructions to avoid its occurrence, and how the issue will be resolved. Customers are to ensure that the Safety Advisory is placed in the system's instructions for use and contact their SIEMENS Uptime Service Senter if they have any questions.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution -- including states of AL, CA, CT, FL, LA, MI, MO, NC, NJ, OH, PA, TN, and WI.

Official Source

View FDA Recall →

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

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