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, 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 January 27, 2009).
- Recall Initiated
- November 21, 2008
- Posted
- January 27, 2009
- Terminated
- September 6, 2010
- Recall Number
- Z-0928-2009
- Quantity
- 476 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
Distribution
Worldwide Distribution including USA and country of Canada.
Lot / Code Info
Software version 2.1.5.5 and 3.0.4 and higher.
Root Cause
Software design
Action Taken
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 11/21/08 of the software anomaly resulting in a patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. The letter provided the users with safety instructions to follow until the software is updated. Please 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 414-918-4653.