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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity AW Suite 2.0 Software

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 Class 2 Recall
Centricity AW Suite 2.0 Software
see related information
Date Posted September 02, 2008
Recall Status1 Terminated on September 24, 2010
Recall Number Z-1825-2008
Recall Event ID 47840
Premarket Notification
510(K) Number
K061372 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Code Information software version 2.0
Recalling Firm/
Manufacturer
GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington, Illinois 60010-3051
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall
Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IITS sent Urgent Safety Notice letters dated 5/9/08 to all customers who have the AW Suite Software Version 2.0, informing them of the incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta analysis protocol or customized protocols. The users were instructed not to use the aorta analysis protocol or the customized protocols for an aneurysm 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 207 units
Distribution Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Japan, Malaysia, Malta, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland and Turkey.
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 HEALTHCARE INFORMATION TECHNOLOGIES
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