Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 9/17/2008
Class:ll
PRODUCT
GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; Recall # Z-1825-2008
REASON
Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 9, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide and Internationally
