| Class 2 Device Recall Centricity Perinatal and Centricity Intensive Care |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HGM
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