Recall Z-0112-2009 ยท HGM System, Monitoring, Perinatal
GE Healthcare Integrated IT Solutions
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; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
| Date | Oct 15, 2008 (initiated Sep 25, 2008) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 8 |
| Quantity | 470 units |
| Distribution | Worldwide Distribution --- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993008 | QUANTITATIVE SENTINEL SYSTEM Marquette Medical Systems, Inc., Dec 6, 1999 |