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 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-0928-2009
REASON
There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 21, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
476 units
DISTRIBUTION
Nationwide and Canada