Company:GE Healthcare Integrated IT Solutions
Date of Enforcement Report 3/4/2009
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-0969-2009
REASON
If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated January 12, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
778 units
DISTRIBUTION
Nationwide, Canada , Bermuda , Mexico , Ecuador , Chile , and Brazil