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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Universal Viewer 6.0,

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  Class 2 Device Recall Centricity Universal Viewer 6.0, see related information
Date Initiated by Firm August 30, 2018
Create Date October 18, 2018
Recall Status1 Terminated 3 on August 31, 2022
Recall Number Z-0195-2019
Recall Event ID 81297
510(K)Number K150420  
Product Classification System, image processing, radiological - Product Code LLZ
Product Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Code Information SYSTEM ID: 315470CPUWPV  UDI #: 8406821038 00DE #: 2090255-001 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
FDA Determined
Cause 2
Component design/selection
Action On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 1
Distribution NY
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 = GE HEALTHCARE