FDA Device recall Z-1175-2014
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 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 issues include both NIBP (Non-Invas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1175-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-28 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 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(NMT) 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. K092027 CARESCAPE Monitor B850 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. K131414 CARESCAPE MONITOR B850 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, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N
Reason
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues.
Identifiers
| code_info | Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380…Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380503HA SEW13380504HA SEW13380505HA SEW13380506HA SEW13380507HA SEW13380508HA SEW13380509HA SEW13380512HA SEW13380520HA SEW13380524HA SEW13380525HA SEW13380526HA SEW13380534HA SEW13380535HA SEW13380536HA SKA13130068GA SKA13130071GA SKA13130075GA SKA13130077GA SKA13130078GA SKA13130082GA SKA13130085GA SKA13140118GA SKA13370167GA SKA13370211GA SKA13370214GA SKA13370215GA SKA13370216GA SKA13370217GA SKA13370218GA SKA13370219GA SKA13370220GA SKA13370221GA SKA13370222GA SKA13370223GA SKA13370224GA SKA13370225GA SKA13370226GA SKA13370227GA SKA13370228GA SKA13370229GA SKA13370230GA SKA13370231GA SKA13370232GA SKA13370233GA SKA13370234GA SKA13370235GA SKA13370236GA SKA13370237GA SKA13370238GA SKA13370239GA SKA13370240GA SKA13370241GA SKA13370242GA SKA13370263GA SKA13370265GA SKA13370267GA SKA13370268GA SKA13370269GA SKA1 |
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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-1175-2014%22
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