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. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
This recall has been terminated (originally issued February 3, 2009).
- Recall Initiated
- November 20, 2008
- Posted
- February 3, 2009
- Terminated
- February 3, 2010
- Recall Number
- Z-0970-2009
- Quantity
- 22 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
Distribution
California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.
Lot / Code Info
Software versions 2.1.X and 3.0.X and higher with Talk Extend
Root Cause
Software design
Action Taken
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. 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.