Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 12/17/2008
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-0460-2009
REASON
Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated September 25, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
546 units
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela
