Centricity Perinatal and Centricity Intensive Care is intended to be… — Class II medical device recall Z-0337-2014
Terminated recall by GE Healthcare It, reported 2013-11-27, distributed nationwide. 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient sl
| Recall number | Z-0337-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare It, Barrington, IL, United States |
| Recall initiated | 2013-03-11 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2016-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, DK, GB, HK, KR, TH |
| Quantity | 1,132 units |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0337-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.