Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 11/5/2008
Class:ll

PRODUCT
Centricity Perinatal (formerly Quantitative Sentinel) System – Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-0112-2009

REASON
On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated April 20, 2007 and August 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
470 units

DISTRIBUTION
Nationwide and Internationally