Z-0337-2014Class II

Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare...

Name: Z-0337-2014 Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare...
Creator: GE Healthcare It
Published: 2013-03-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-03-11 / Terminated / root cause: software

FDA source

GE Healthcare It began a recall of Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery... on 2013-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0337-2014
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Posted: 2013-11-18
Terminated: 2016-06-10
Recalling firm: GE Healthcare
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.
Product code: HGM System, Monitoring, Perinatal
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
Root cause tag: software
FDA root cause: 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 [email protected]. 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0337-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0337-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code HGM

K111614Class IICentricity Perinatal and Centricity Intensive CareGe Healthcare Integrated IT Solutions / cleared 2011-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)