Z-0456-2009

GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software...

Name: Z-0456-2009 GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-09-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-09-25 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical... on 2008-09-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0456-2009
Status: Terminated
Initiated: 2008-09-25
Posted: 2008-12-03
Terminated: 2008-12-03
Recalling firm: GE Healthcare
Product: 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.
Product code: HGM System, Monitoring, Perinatal
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.
Root cause tag: software
FDA 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 in commerce: 1 unit
Distribution: Nationwide Distribution --- state of Ohio.
Product codes and lots: software version 6.80.0 only with Alert and Reminder feature activated

Product code HGM

K993008Class IIQuantitative Sentinel SystemMarquette Medical Systems, Inc. / cleared 1999-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)