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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity AW Suite Software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus

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 Class 2 Recall
GE Centricity AW Suite Software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on September 06, 2010
Recall Number Z-2183-2008
Recall Event ID 48637
Premarket Notification
510(K) Number
K061372 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Code Information Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Module
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
When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IITS sent Product Safety Notification letters dated 6/11/08 to all customers who have the AW Suite Software Versions 2.0 and 2.0.1, informing them that if they also have Card IQ Xpress Pro or Plus, the AW Suite Card IQ software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the restored images. This failure only occurs when users create a custom label in the vessel analysis protocol and include leading or trailing blank characters (space bar) in the custom label. The users were instructed not to make any clinical decisions based on a Card IQ Save State when a custom label has been ordered, and not to include leading or trailing blank characters (space bar) in the new branch name when customizing a Card IQ vessel analysis protocol 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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