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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 September 02, 2008
Recall Status1 Terminated on February 03, 2010
Recall Number Z-1826-2008
Recall Event ID 48078
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 version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
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
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time until the new software version can be installed. A software patch to permanently resolve the issue will be installed at no charge. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Quantity in Commerce 177 units
Distribution Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and 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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