| Class 2 Device Recall Syngo Dynamics | |
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
|
|
|
|