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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Universal Viewer Image Processing System

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  Class 2 Device Recall Centricity Universal Viewer Image Processing System see related information
Date Initiated by Firm December 16, 2019
Date Posted January 17, 2020
Recall Status1 Terminated 3 on October 05, 2023
Recall Number Z-0819-2020
Recall Event ID 84584
510(K)Number K182419  K150420  
Product Classification System, image processing, radiological - Product Code LLZ
Product Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Code Information Model 2088026-9XX Versions 6.0 SP10 or higher
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
FDA Determined
Cause 2		 Software design
Action The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.
Quantity in Commerce 205
Distribution Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
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
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