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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Perinatal and Centricity Intensive Care

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  Class 2 Device Recall Centricity Perinatal and Centricity Intensive Care see related information
Date Initiated by Firm March 11, 2013
Date Posted November 18, 2013
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-0337-2014
Recall Event ID 64805
510(K)Number K111614  
Product Classification System, monitoring, perinatal - Product Code HGM
Product Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.
Code Information Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1
Recalling Firm/
Manufacturer		 GE Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact
800-433-2009
Manufacturer Reason
for Recall		 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 11, 2013, to all affected customers. The letters requested that direct accounts ensure that all potential users of the software were made aware of the potential problems and the recommended actions. Direct accounts were asked to return a customer response form and to return it to GE Healthcare via fax at 847-939-1522 or e-mail at QARAFMl1@ge.com. Version 6.94 of the software has been modified to correct these defects. GE Technical Support: 800-433-2009.
Quantity in Commerce 1,132 units
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.
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 = GE HEALTHCARE INTEGRATED IT SOLUTIONS
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