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 (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.

Recommended Action

Per FDA guidance

GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 1/12/09 of the software anomaly resulting in a patient safety issue involving Default Display Protocols. The issue may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed 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 847-939-1479.