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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo.via

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  Class 2 Device Recall Syngo.via see related information
Date Initiated by Firm August 05, 2016
Date Posted September 21, 2016
Recall Status1 Terminated 3 on August 22, 2017
Recall Number Z-2853-2016
Recall Event ID 75143
510(K)Number K123375  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.via picture archiving and communication system

Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Code Information Serial Numbers: 220755 101060 220807 221363 220497 221053 100662 130301 101494 130643 101312 310364 102213 221225 130653 220687 220811 310395 102048 100741 102523 101739 221244 102125 102401 310397 102036 220939 100915 221110 100598 130765 130321 130118 310310 102477 130692 102008 130159 101757 101773 100751 100713 101802 102535 310536 221199 102089 220451 101559 101479 130252 100417 100421 100641 100642 100644 100646 100418 100419 100420 100643 100645 100811 100812 100813 100814 102369 101521 221129 310363 220909 400047 100669 130326 101839 311011 130712 131011 101027 100744 130784 310524 311001 101313 101233 101114 221192 130201 130180 220604 100518 100735 102296 130629 102532 102158 101843 102447 102533 220930 102515 220684 220725 130908 102271 130309 102265 101638 102449 102377 102553 130396 101864 101826 102563 102374 100704 102340 310365 310388 102197 101938 100929 310348 100963 100729 221280 102229 102537 130852 100008 101355 101163 101192 102409 130539 101201 102490 101051 101205 101220 101202 101206 101854 220448 220466 400058 400061 130438 101046 101565 101612 102381 101855 101784 310486 101561 102113 221299 102064 101225 101515 221154 130628 130174 130175 130777 130635 102526 101834 102418 101183 102120 130377 101137 101740 220577 100485 221344 130569 221264 102455 130125 101701 100950 130267 101885 130716 101578 221345 310472 102108 100692 100826 102175 101371 100675 100700 101257 130229 220617 102142 130734 310396 102021 100760 101338 101354 130491 101566 130410 310460 101878 310410 130241 130242 130243 130244 102281 101251 101309 101631 130630 102031 100796 130563 102270 102405 220512 130916 130611 100620 101444 100957 310379 100039 130335 101998 130695 102417 221233 101043 101066 311012 101503 400062 100677 400065 221204 102127 101416 130837 100012 101267 130745 220855 102420 221390 102146 102511 220742 130149 102486 130376 101797 220288 101754 100633 101602 221319 102363 130266 102499 220454 102013 102291 102297 102298 101722 101723 101953 221296 221257 101520 100753 220876 130561 130140 221109 130631 221254 100734 101345 102560 101316 102576 130803 400042 220465 100411 101367 101958 100484 100583 101020 101182 100590 130711 220900 130386 101038 130327 101057 102444 220964 102097 100978 102470 100763 130751 130449 130761 130173 102475 131012 101010 130443 102209 310385 101650 130247 100771 100742 310418 130697 220163 102360 
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		 Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Customer Letter dated August 5, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The letter informed customers of a software change VB10B_HF02 that they have implemented to address several issues. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions please call (610) 219-4834.
Quantity in Commerce 338 systems
Distribution Distributed Nationwide
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 = SIEMENS AG
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