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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 January 25, 2016
Create Date March 17, 2016
Recall Status1 Terminated 3 on June 29, 2018
Recall Number Z-1183-2016
Recall Event ID 73479
510(K)Number K023772  K102150  
Product Classification System, image processing, radiological - Product Code LLZ
Product Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673


intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
Code Information Serial #:  85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Anastasia Sokolova
610-448-6478
Manufacturer Reason
for Recall		 Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
FDA Determined
Cause 2		 Software design
Action The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2016 to customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions provided on what steps the user can take to avoid the issue and to forward the notice to the new owner, if you sold this device/equipment and its no longer in your possession. Siemens is preparing a modification of syngo Dynamics that will resolve this potential malfunction. If you have any question, contact Regulatory Technician Specialist at 610-448-6478 or email: Anastasia.sokolova@siemens.com.
Quantity in Commerce 228 units
Distribution US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.
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.
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