GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analy
FDA device recall Z-2183-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare Integrated IT Solutions
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, S
- Date initiated
- 2008-06-11
- Date posted
- 2008-09-16
- Date terminated
- 2010-09-06
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY AW SUITE OPTION (K061372) | Ge Healthcare Information Technologies | 2006-05-30 |