Model note · Ventilator

GE CARESCAPE R860 critical care ventilator

Name: GE CARESCAPE R860 critical care ventilator
Brand: GE CARESCAPE R860

The CARESCAPE R860 is a GE critical care ventilator for neonatal, pediatric and adult patients from 0.25 kg, used in the unit and for transport inside the hospital. A touchscreen display unit sits on a separate ventilator unit, and optional plug in Datex-Ohmeda gas modules add respiratory gas monitoring, SpiroDynamics and functional residual capacity measurement. Software v11 (K210384, 2021) added a high flow O2 Therapy mode for patients over 10 kg. The record that matters most for engineers is the backup battery: a 2022 correction covered 34,940 GE ventilators whose batteries could shut the ventilator down early off mains, and 'failure to run on battery' leads its MAUDE reports by far.

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The model

Maker, model and type.

Maker: Datex-Ohmeda, Inc. (GE HealthCare)
Model: CARESCAPE R860 critical care ventilator (v10 and v11 software)
Device type: Ventilator
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification and clearances	Continuous ventilator, product code CBK; K142679 (12 June 2015, v10) and K210384 (4 November 2021, v11)	Source
Patients and use	Neonatal, pediatric and adult patients weighing 0.25 kg and above; healthcare facility use including transport within the facility; O2 Therapy only for adults and children over 10 kg	Source
Modes	A/C VC, A/C PC, A/C PRVC, SIMV VC, SIMV PC, SIMV PRVC, BiLevel, BiLevel VG, CPAP/PS, VS, APRV, NIV (not in neonatal mode), nCPAP, SBT, apnea backup; plus O2 Therapy (v11)	Source
Architecture	Microprocessor based, pneumatically controlled ventilator with integrated FiO2, airway pressure, spirometry and volume monitoring; display unit with resistive touchscreen and Trim Knob, and a separate ventilator unit	Source
Options	Integrated Datex-Ohmeda gas modules powered by the ventilator; SpiroDynamics; FRC calculation in ventilated patients	Source
Contraindication	Not a pulmonary function calculation device	Source

Recalls

Known FDA recalls.

Z-1226-20222022-04-18
Backup batteries could give insufficient power and shut the ventilator down early off mains (R860 and Engstrom family; 34,940 ventilators).
FDA record
Z-2883-20202020-07-14
Oxygen sensor could display an FiO2 different from the delivered value (2,277 units).
FDA record
Z-0463-20192018-10-05
Inspiratory Safety Guard parts 2066713-001 and 2083208-001 could disconnect from the breathing circuit path.
FDA record
Z-2738-20182018-06-28
Neonatal flow sensor cable missing its connector housing.
FDA record
Z-2266-20182017-12-08
Software 10SP05 display processor failure, error code EC01 XX.
FDA record

Safety

Safety warnings from the record.

If the ventilator must run on battery, for example in transport, keep a bag valve device and someone able to use it at hand at all times (GE 2022 instruction). Source
A disconnected Inspiratory Safety Guard can cause loss of ventilation and hypoxia. Source

Sources

Where this note comes from.

Not covered: GE's User's Reference Manual links found online now return errors, so setting ranges (tidal volume, flows, pressures), battery run time, weight and maintenance intervals are not included. A distributor sheet gives battery backup as up to 85 minutes with a 30 minute minimum, but that is not from GE and is left out. Only error code EC01 XX is named, from an FDA recall record.

BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.

Ventilator