GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
- Company
- Ge Healthcare It
- Recall Initiated
- February 18, 2010
- Posted
- April 15, 2010
- Terminated
- June 10, 2016
- Recall Number
- Z-1395-2010
- Quantity
- 36 units
- Firm Location
- Barrington, IL
Reason for Recall
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.
Distribution
Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Lot / Code Info
Software version 3.7.7.x
Root Cause
Software design
Action Taken
An "Urgent Medical Device Correction" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers 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. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.