Recall Z-2037-2008 ยท HGM System, Monitoring, Perinatal
GE Healthcare Integrated IT Solutions
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.
| Date | Jul 30, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare notified their Centricity Perinatal customers via letter dated 7/20/07 of the problem with the PFILS application that could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. The letter provided the users with a workaround and provided them with a Frequently Asked Questions document which listed the availability of a software patch to fix the problem. A follow-up letter dated 6/27/08 was sent on 6/30-7/2/08 to those accounts who had not requested a PFILS Hotfix CD-ROM or had not had their software recentl |
| Quantity | 1,031 units |
| Distribution | Worldwide: USA, Puerto Rico, Canada, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993008 | QUANTITATIVE SENTINEL SYSTEM Marquette Medical Systems, Inc., Dec 6, 1999 |