Z-0112-2009

Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic...

Name: Z-0112-2009 Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic...
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 Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information... on 2008-09-25. The reason FDA records is "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". 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-0112-2009
Status: Terminated
Initiated: 2008-09-25
Posted: 2008-10-15
Terminated: 2010-05-17
Recalling firm: GE Healthcare
Product: 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
Product code: HGM System, Monitoring, Perinatal
Reason for recall: 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 tag: software
FDA 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 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.
Quantity in commerce: 470 units
Distribution: Worldwide Distribution --- including USA and country of Canada.
Product codes and lots: software version 6.70.6 of the Centricity Perinatal clinical information system

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)