Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 2/18/2009
GE Centricity PACS RA1000 Workstation (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-0970-2009
Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 10, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
CA, FL, IL, IA, LA, OR, PA, TX, UT, VA, and WI