Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 7/23/2008
Class:ll
PRODUCT
GE Healthcare Centricity Perinatal (formerly QS) System – PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-2037-2008
REASON
Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated July 20, 2007 and June 27, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,031 CD-ROMs
DISTRIBUTION
Nationwide and Internationally
