Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 9/17/2008
Class:ll
PRODUCT
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; Recall # Z-1826-2008
REASON
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 5, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
Nationwide and Internationally
