GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Brand
GE Healthcare Integrated IT Solutions
Lot Codes / Batch Numbers
GE Centricity PACS RA1000 Workstation software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
Products Sold
GE Centricity PACS RA1000 Workstation software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
GE Healthcare Integrated IT Solutions is recalling GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT So due to A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potenti. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026