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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens syngo Dynamics

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 Class 2 Device Recall Siemens syngo Dynamicssee related information
Date Initiated by FirmFebruary 08, 2008
Date PostedSeptember 29, 2008
Recall Status1 Terminated 3 on November 18, 2009
Recall NumberZ-1751-2008
Recall Event ID 46823
510(K)NumberK070322 
Product Classification Picture archiving and communication system - Product Code LLZ
ProductSiemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
Code Information All units with version 6.0 software.
FEI Number 3003304172
Recalling Firm/
Manufacturer		 Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor MI 48108
For Additional Information Contact
734-205-2423
Manufacturer Reason
for Recall		Incorrect data: A software bug may result in a transfer of patient demographic data to a different patient's file.
FDA Determined
Cause 2		Software design
ActionSiemens 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 Commerce18
DistributionNationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LLZ
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