Recall Z-2183-2008 ยท LLZ System, Image Processing, Radiological
GE Healthcare Integrated IT Solutions
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
| Date | Sep 16, 2008 (initiated Jun 11, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061372 | CENTRICITY AW SUITE OPTION Ge Healthcare Information Technologies, May 30, 2006 |