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U.S. Department of Health and Human Services

Class 2 Device Recall SYNGO IMAGING (VERSION V30 and V31)

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  Class 2 Device Recall SYNGO IMAGING (VERSION V30 and V31) see related information
Date Initiated by Firm June 11, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-1972-2015
Recall Event ID 71507
510(K)Number K081734  K071114  
Product Classification System, image processing, radiological - Product Code LLZ
Product SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Code Information model number: 10014064 serial numbers: 5846 5847 4333 4334 4335 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
FDA Determined
Cause 2		 Software design
Action Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.
Quantity in Commerce 5
Distribution US in the states of NC and NE
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, MEDICAL SOLUTIONS
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