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Terminated

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.

FDA Recall Z-0337-2014 · Posted 2013-11-18

Recalling FirmGE Healthcare It
Recall StatusTerminated
Product CodeHGM
Date Initiated2013-03-11
Date Terminated2016-06-10
Product Quantity1,132 units

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

Firm 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 [email protected]. Version 6.94 of the software has been modified to correct these defects. GE Technical Support: 800-433-2009.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111614CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CAREGe Healthcare Integrated IT Solutions · 2011-09-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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