GE Centricity PACS RA1000 Workstation software (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 July 13, 2009).
- Recall Initiated
- March 24, 2009
- Posted
- July 13, 2009
- Terminated
- September 6, 2010
- Recall Number
- Z-1543-2009
- Quantity
- 984 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
Distribution
Worldwide Distribution - US including Puerto Rico and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey.
Lot / Code Info
Software Versions: Centricity 1.X, 2.0.X, 2.1.X and 3.0.X and PathSpeed 7.X and 8.X.
Root Cause
Software design
Action Taken
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation Software Versions 2.1.x and 3.0.x customers via an Urgent Medical Device Correction notice dated March 2, 2009 of the affected device resulting in patient safety issues. The letter provided users with safety instructions until the software is updated. Consignees are requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 1-847-939-1479. Centricity PACS RA1000 Workstation Software Versions PathSpeed 7.x, 8.x, Centricity 1.X and 2.0.X customers were sent separate letters explaining the recall including instructions. There will be no software updates since those software versions are no longer being supported. For questions, call the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.