10

Dec

2008

Cl Ill GE Healthcare Centricity Perinatal System

0

Company: GE Healthcare Integrated IT Solutions
Date of Enforcement Report 12/10/2008
Class:lll

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; Recall # -0456-2009

REASON
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.

RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated August 29, 2008. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
OH

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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