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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision

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  Class 2 Device Recall Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision see related information
Date Initiated by Firm September 25, 2008
Date Posted October 15, 2008
Recall Status1 Terminated 3 on May 17, 2010
Recall Number Z-0112-2009
Recall Event ID 49459
510(K)Number K993008  
Product Classification Perinatal Monitoring System - Product Code HGM
Product Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision 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
Code Information software version 6.70.6 of the Centricity Perinatal clinical information system
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		 On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.
FDA Determined
Cause 2		 Software design
Action GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.
Quantity in Commerce 470 units
Distribution Worldwide Distribution --- including USA and country of Canada.
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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