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U.S. Department of Health and Human Services

Class 2 Device Recall Picture Archiving and Communication System

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  Class 2 Device Recall Picture Archiving and Communication System see related information
Date Initiated by Firm January 18, 2016
Date Posted April 07, 2016
Recall Status1 Terminated 3 on August 03, 2017
Recall Number Z-1349-2016
Recall Event ID 73475
510(K)Number K071114  K081734  
Product Classification System, image processing, radiological - Product Code LLZ
Product 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 # 10014063
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		 To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
FDA Determined
Cause 2		 Software design
Action Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
Quantity in Commerce 49 imaging systems
Distribution US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and 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 and Original Applicant = SIEMENS AG, MEDICAL SOLUTIONS
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