GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images 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. The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images
Brand
GE Healthcare Integrated IT Solutions
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
GE Centricity PACS RA1000 Workstation software versions: 1) Software version 2.1.X (from 2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases prior to 2.1.5.1 for the default display protocol issue), and 2) Software version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
GE Healthcare Integrated IT Solutions is recalling GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT S due to Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization wit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the curr
Recommended Action
Per FDA guidance
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation customers via letter (Product Safety Notification) dated 9/25/08 of the software anomalies resulting in patient safety issues involving the patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa. The letter provided the users with safety instructions to follow until the software is updated. Direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-277-5240.
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