Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
This recall has been terminated (originally issued January 12, 2009).
- Recall Initiated
- December 12, 2008
- Posted
- January 12, 2009
- Terminated
- May 18, 2010
- Recall Number
- Z-0870-2009
- Quantity
- 742 units
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.
Distribution
Worldwide Distribution including USA and countries of Australia, Austria, Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway, Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Lot / Code Info
Software versions 3.0, 3.0.1, 3.0.1.1, 3.0.2, 3.0.3, and 3.0.4
Root Cause
Software design
Action Taken
GE Healthcare Integrated IT Solutions notified their Centricity Enterprise Web software customers via letter (Urgent Medical Device Correction) dated 12/12/08 of the software anomalies resulting in patient safety issues involving a forced log off during an open session while using the Centricity Enterprise Web and measurements displayed in Centricity Enterprise Web will use the calibration provided by the original scanning modality. Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation. 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 414-918-4653. For further information, please contact GE Customer Care Center by telephone at 800-437-1171.