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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity PACS

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  Class 2 Device Recall Centricity PACS see related information
Date Initiated by Firm June 14, 2022
Create Date July 25, 2022
Recall Status1 Terminated 3 on January 16, 2024
Recall Number Z-1466-2022
Recall Event ID 90525
510(K)Number K110875  
Product Classification System, image processing, radiological - Product Code LLZ
Product Centricity PACS Software Version 7.0 SP0.0.4.7
Code Information Model: 5831882-012, Software Version 7.0 SP0.0.4.7 GTIN: 00840682145572
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction letter was sent to customers beginning June 14, 2022. The letter informs the customer of the issue and provides safety instructions for continued use of the device. GE Healthcare will correct all affected devices via a software update. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics.
Quantity in Commerce 47 installations
Distribution Worldwide distribution - US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.
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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