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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder

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  Class 2 Device Recall Centricity Perinatal (formerly Quantitative Sentinel) System Alert and Reminder see related information
Date Initiated by Firm September 25, 2008
Date Posted December 03, 2008
Recall Status1 Terminated 3 on December 03, 2008
Recall Number Z-0456-2009
Recall Event ID 49460
510(K)Number K993008  
Product Classification Perinatal Monitoring System - Product Code HGM
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.
Code Information software version 6.80.0 only with Alert and Reminder feature activated
Recalling Firm/
Manufacturer		 GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution --- state of Ohio.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGM and Original Applicant = MARQUETTE MEDICAL SYSTEMS, INC.
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