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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 January 08, 2018
Date Posted March 20, 2018
Recall Status1 Terminated 3 on April 22, 2020
Recall Number Z-1303-2018
Recall Event ID 79532
510(K)Number K123375  
Product Classification System, image processing, radiological - Product Code LLZ
Product Syngo.via. Medical Device Software. Picture archiving and communications system.
Code Information Model Number 10496180
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		 A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
FDA Determined
Cause 2		 Software design
Action Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.
Quantity in Commerce 236 units
Distribution Device is software only. No products are distributed to wholesale dealers, distributers or retailers
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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