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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS Workstation

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  Class 2 Device Recall GE Centricity PACS Workstation see related information
Date Initiated by Firm November 15, 2012
Create Date August 17, 2016
Recall Status1 Terminated 3 on December 13, 2017
Recall Number Z-2579-2016
Recall Event ID 64785
510(K)Number K043415  
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System

Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
Code Information Centricity PACS versions 3.1.1.x through 3.2.1.x
Recalling Firm/
Manufacturer		 GE Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact Jeme Wallace
847-277-5000
Manufacturer Reason
for Recall		 While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
FDA Determined
Cause 2		 Software design
Action GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196.
Quantity in Commerce 498 units
Distribution Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
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 MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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