Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0870-2009

Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical...

GE Healthcare / initiated 2008-12-12 / Terminated / root cause: software

GE Healthcare Integrated IT Solutions began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0870-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
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.
Product code
LMD System, Digital Image Communications, Radiological
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.
Root cause tag
software
FDA root cause
Software design
Action
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.
Quantity in commerce
742 units
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.
Product codes and lots
Software versions 3.0, 3.0.1, 3.0.1.1, 3.0.2, 3.0.3, and 3.0.4