Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 7/22/2009
Class:ll
PRODUCT
GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. 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-1543-2009
REASON
Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue..
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated March 2, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
984 units
DISTRIBUTION
Nationwide and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey.
