| Class 2 Device Recall Centricity AW Suite 2.0 Software | |
Date Initiated by Firm | May 09, 2008 |
Date Posted | September 02, 2008 |
Recall Status1 |
Terminated 3 on September 24, 2010 |
Recall Number | Z-1825-2008 |
Recall Event ID |
47840 |
510(K)Number | K061372 |
Product Classification |
Radiologic Image Processing System - Product Code LLZ
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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 IL 60010-3051
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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 | 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 |
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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
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