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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS RA1000 Workstation

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 Class 2 Recall
GE Centricity PACS RA1000 Workstation
see related information
Date Posted January 25, 2007
Recall Status1 Terminated on February 03, 2010
Recall Number Z-0373-2007
Recall Event ID 37121
Premarket Notification
510(K) Number
K043415 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Code Information GE Centricity PACS RA1000 Workstation Software versions 2.1.X.X. and 3.0.X.X. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential.
Recalling Firm/
Manufacturer
GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington, Illinois 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Quantity in Commerce 198 units
Distribution Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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