FDA Recall Terminated

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.

Recall: Z-0456-2009 · Initiated September 25, 2008

Recall

Recall Number
Z-0456-2009
Event Number
49460
Firm
GE Healthcare Integrated IT Solutions
FEI Number
3004526608
Product Code
HGM
Status
Terminated
Root Cause
Software design
Initiated
September 25, 2008
Posted
December 3, 2008
Terminated
December 3, 2008
Address
540 W Northwest Hwy, Barrington, IL, 60010-3051

Description

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.

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.

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.

Distribution

Nationwide Distribution --- state of Ohio.

Quantity

1 unit