FDA Device recall Z-0854-2014
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850 by Ge Healthcare, citing GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0854-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-27 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
Reason
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.
Identifiers
| code_info | Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED1302…Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED13027435GA 2020913-002 SED13027444GA 2020913-002 SEW11456764HA M1176021-094955 SEW11487296HA M1176021-094955 SEW11487300HA M1176021-094955 SEW11487304HA M1176021-094955 SEW11487306HA M1176021-094955 SEW11487307HA M1176021-094955 SEW11487308HA M1176021-094955 SEW11487309HA M1176021-094955 SEW11487310HA M1176021-094955 SEW11487312HA M1176021-094955 SEW11487313HA M1176021-094955 SEW11487314HA M1176021-094955 SEW11487315HA M1176021-094955 SEW11487316HA M1176021-094955 SEW11487317HA M1176021-094955 SEW11497510HA M1176021-094955 SEW11497511HA M1176021-094955 SEW11497512HA M1176021-094955 SEW11497513HA M1176021-094955 SEW11497514HA M1176021-094955 SEW11497515HA M1176021-094955 SEW11497517HA M1176021-094955 SEW11497518HA M1176021-094955 SEW11497519HA M1176021-094955 SEW11497532HA M1176021-094955 SEW11497534HA M1176021-094955 SEW11497535HA M1176021-09495 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0854-2014%22
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