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
FDA Recall Z-1825-2008 · Posted 2008-09-02
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Recalling FirmGE Healthcare Integrated IT Solutions
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-05-09
Date Terminated2010-09-24
Product Quantity207 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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