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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo Dynamics

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  Class 2 Device Recall Syngo Dynamics see related information
Date Initiated by Firm April 14, 2016
Date Posted May 04, 2016
Recall Status1 Terminated 3 on March 20, 2017
Recall Number Z-1601-2016
Recall Event ID 73907
510(K)Number K023772  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Code Information Model Numbers: 10091637, 10091673, 10091805, 10091807  Serial Numbers: 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185, 85186, 85189, 85191, 85234, 85235, 85239, 85281, 85307, 85309, 85322, 85325, 85326, 85329, 85335, 85338, 85350, 85353, 85354, 85368, 85370, 85374, 85377, 85380, 85385, 85387, 85401, 85418, 85421, 85422, 85427, 85435, 85442, 85447, 85462, 85467, 85468, 85469, 85470, 85473, 85481, 85482, 85484, 85859, 85860, 85866, 85867, 85871, 85872, 85873, 85874, 85875, 85876, 85880, 85883, 85884, 85893, 85896, 85910, 85918
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.
FDA Determined
Cause 2		 Software design
Action Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.
Quantity in Commerce 84 units
Distribution Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI
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.
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