GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
This recall has been terminated (originally issued January 25, 2007).
- Recall Initiated
- January 12, 2007
- Posted
- January 25, 2007
- Terminated
- February 3, 2010
- Recall Number
- Z-0373-2007
- Quantity
- 198 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
Distribution
Worldwide including USA, Australia, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey and the United Kingdom.
Lot / Code Info
GE Centricity PACS RA1000 Workstation Software versions 2.1.X.X. and 3.0.X.X. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential.
Root Cause
Other
Action Taken
GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.