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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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Date Initiated by Firm |
June 11, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on September 06, 2010 |
Recall Number |
Z-2183-2008 |
Recall Event ID |
48637 |
510(K)Number |
K061372
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Product Classification |
System, Image processing, radiological - Product Code LLZ
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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 IL 60010-3051
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For Additional Information Contact |
GE Customer Care Center 800-437-1171
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE INFORMATION TECHNOLOGIES
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