Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 7/8/2009
Class:ll

PRODUCT
GE Centricity PACS (Picture Archiving and Communication System) software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-1549-2009

REASON
There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated April 2, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,188 units

DISTRIBUTION
Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom