Company:GE Healthcare Integrated IT Solutions.
Date of Enforcement Report 2/4/2009
Class:ll
PRODUCT
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. 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. Recall # Z-0836-2009
REASON
There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December 12, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
Nationwide and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom
