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Terminated

Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355

FDA Recall Z-1038-2008 · Posted 2008-04-29

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-12-21
Date Terminated2008-09-30
Product Quantity47 Units

Reason for Recall

Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

Firm Action

Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040970LEONARDOSiemens Medical Systems, Inc. · 2004-07-08

Official Source

View FDA Recall →

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

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