GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
This recall has been terminated (originally issued September 2, 2008).
- Recall Initiated
- May 6, 2008
- Posted
- September 2, 2008
- Terminated
- February 3, 2010
- Recall Number
- Z-1826-2008
- Quantity
- 177 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
Distribution
Nationwide and internationally to Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Malta, South Korea, Spain, Switzerland and United Kingdom.
Lot / Code Info
GE Centricity PACS RA1000 Workstation software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
Root Cause
Software design
Action Taken
GE Healthcare IITS sent Product Safety Notification letters dated 5/5/08 to all customers who have the GE Centricity PACS Software Versions 3.0.0.X, 3.0.1.X, 3.0.2.X and 3.0.3.X informing them of the incorrect study date and time information being displayed in the report screen and title, which may lead to a potential patient misdiagnosis. The users were instructed to refer to the image overlay for the correct date and time 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.