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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 Recall
Siemens syngo Dynamics
see related information
Date Posted September 29, 2008
Recall Status1 Terminated on November 18, 2009
Recall Number Z-1751-2008
Recall Event ID 46823
Premarket Notification
510(K) Number
K070322 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
Code Information All units with version 6.0 software.
Recalling Firm/
Manufacturer
Siemens Medical Solutions, USA, Inc
400 Morgan Rd
Ann Arbor, Michigan 48108
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
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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