Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1751-2008

Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system

Siemens Medical Solutions USA, Inc. / initiated 2008-02-08 / Terminated / root cause: software

Siemens Medical Solutions, USA, Inc began a recall of Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system on . The reason FDA records is "Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1751-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
Product code
LLZ System, Image Processing, Radiological
Reason for recall
Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.
Root cause tag
software
FDA root cause
Software design
Action
Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.
Quantity in commerce
18
Distribution
Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.
Product codes and lots
All units with version 6.0 software.