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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 Dynamics see related information
Date Initiated by Firm January 27, 2014
Date Posted March 18, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-1216-2014
Recall Event ID 67559
510(K)Number K102150  K023772  
Product Classification Picture Archiving and Communication System (PACS) - Product Code LLZ
Product syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Code Information Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
FDA Determined
Cause 2
Software design
Action A recall notification letter, dated January 27, 2014, was sent to end Users. Customer Safety Advisory Letter SY016/14/S. Siemens is preparing a Service Patch modification of syngo Dynamics v9.5 which will be available in March 2014.
Quantity in Commerce 50
Distribution Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = ACUSON CORP.
510(K)s with Product Code = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.