Device Recall Centricity Perinatal (formerly QS) System PFILS software 의 리콜

Recall

48755

Class 2

Z-2037-2008

2008-06-30

2008-07-30

Terminated

United States

2010-09-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72063

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.

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.