Z-2037-2008

GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic...

Name: Z-2037-2008 GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic...
Creator: GE Healthcare Integrated IT Solutions
Published: 2008-06-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-06-30 / Terminated / root cause: software

FDA source

GE Healthcare Integrated IT Solutions began a recall of GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical... on 2008-06-30. The reason FDA records is "Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording...". 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-2037-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-07-30
Terminated: 2010-09-06
Recalling firm: GE Healthcare
Product: GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.
Product code: HGM System, Monitoring, Perinatal
Reason for recall: Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified their Centricity Perinatal customers via letter dated 7/20/07 of the problem with the PFILS application that could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. The letter provided the users with a workaround and provided them with a Frequently Asked Questions document which listed the availability of a software patch to fix the problem. A follow-up letter dated 6/27/08 was sent on 6/30-7/2/08 to those accounts who had not requested a PFILS Hotfix CD-ROM or had not had their software recently upgraded. The letter a copy of the 7/20/07 letter, the most recent FAQ, the PFILS Hotfix CD (PFIL67_66) and Installation Procedure for the PFILS Patch instructions for installation of the software patch. The accounts were advised that they can request an analysis of existing patient records to determine whether they have been affected by the PFILS issue, by submitting a non-critical Technical Support Request on the GE Centricity Perinatal Web site: http://www.gehealthcare.com/usen/security/cis/stupgrades.html, indicating "PFILS ANALYSIS REQUEST" in the Description of Issue field. Any questions were directed to Technical Support at 800-433-2009.
Quantity in commerce: 1,031 units
Distribution: Worldwide: USA, Puerto Rico, Canada, and China.
Product codes and lots: All CPN versions up to 6.70.6 P02 with PFILS versions below 2.0

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)