Recall Z-0456-2009 ยท HGM System, Monitoring, Perinatal
GE Healthcare Integrated IT Solutions
GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder 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 Intended for use as a clinical data management system.
| Date | Dec 3, 2008 (initiated Sep 25, 2008) |
| Status | Terminated |
| Reason | Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations. |
| Root cause | Software design |
| Action | The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009. |
| Quantity | 1 unit |
| Distribution | Nationwide Distribution --- state of Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993008 | QUANTITATIVE SENTINEL SYSTEM Marquette Medical Systems, Inc., Dec 6, 1999 |