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.
This recall has been terminated (originally issued December 3, 2008).
- Recall Initiated
- September 25, 2008
- Posted
- December 3, 2008
- Terminated
- December 3, 2008
- Recall Number
- Z-0456-2009
- Quantity
- 1 unit
- Firm Location
- Barrington, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution --- state of Ohio.
Lot / Code Info
software version 6.80.0 only with Alert and Reminder feature activated
Root Cause
Software design
Action Taken
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.