Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 2/18/2009
Class:ll
PRODUCT
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
REASON
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.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 10, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
CA, FL, IL, IA, LA, OR, PA, TX, UT, VA, and WI
