FDA Medical Device Recalls (openFDA)
GE Healthcare Integrated IT Solutions: 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.
- Recall number
- Z-2037-2008
- Recalling firm
- GE Healthcare Integrated IT Solutions
- 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.
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2008-07-30
- Terminated
- 2010-09-06
- Reason
- 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
- 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
- 1,031 units
- Distribution
- Worldwide: USA, Puerto Rico, Canada, and China.
- Lot, serial or model codes
- All CPN versions up to 6.70.6 P02 with PFILS versions below 2.0
- 510(k) numbers
- ["K993008"]
- PMA numbers
- not on file
- Product code
- HGM
- Firm FEI
- 3004526608
- Firm city
- Barrington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28