Model note · Anaesthesia Machine

GE Aisys CS2 anaesthesia delivery system

Name: GE Aisys CS2 anaesthesia delivery system
Brand: GE Aisys CS2

The Aisys CS2 is a GE anaesthesia workstation for neonatal, pediatric and adult patients. Gas flows are mixed electronically and shown on the main display, with an optional traditional flow tube. Agent comes from an electronic vaporiser using Aladin 2 cassettes for isoflurane, desflurane or sevoflurane, which the anaesthesia computer controls. A pneumatically driven ventilator with electronic PEEP offers VCV, PCV, PCV-VG, SIMV and PSVPro modes. Its long recall history is mostly about software, flow sensors and the electronic mixer. In 2026 some mixer assemblies switched to Alternate O2 control, delivering 100% O2 with no agent until a clinician steps in.

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The model

Maker, model and type.

Maker: Datex-Ohmeda, Inc. (GE HealthCare)
Model: Aisys CS2 anaesthesia delivery system (part 1011-9050-000, software 11)
Device type: Anaesthesia Machine
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
FDA classification and clearances	Anaesthesia gas machine, product code BSZ; Aisys from K042154 (2004); Aisys CS2 K132530 (2013) and K170872 (15 August 2017, software 11)	Source
Gas delivery	Electronic gas mixing with electronic flow indicators on the main display; optional traditional flow tube; up to two cylinder yokes mounted inboard; pendant models available	Source
Agent delivery	Electronic vaporiser (technology from the ADU, K973985); Aladin 2 cassette in the active bay holds isoflurane, desflurane or sevoflurane; agent set in percent volume	Source
Ventilator modes	VCV; PCV, SIMV-PC, PCV-VG and PSVPro as options; SIMV/PCV-VG; SIMV/PSV; CPAP-PSV; electronic PEEP	Source
Software 11 additions	Monitor Only mode (gas monitoring with O2 through the auxiliary port, no fresh gas flow), EcoFlow improvements, ACGO handling, sample gas return to the breathing system, cybersecurity changes on the service port, option to hide patient data	Source
Suction requirement	Integrated suction must deliver at least 20 L/min (ISO 10079-3)	Source

Recalls

Known FDA recalls.

Z-3189-20262026-07-30
Certain electronic gas mixers switch to Alternate O2 control: 100% O2, agent delivery interrupted (475 units).
FDA record
Z-0081-20252024-07-12
Breathing circuit limb may be connected to the ACGO port by mistake.
FDA record
Z-1389-20222022-06-01
O2 and air cylinder pressure transducer connections may be reversed.
FDA record
Z-2596-20212021-08-02
Flow sensors built before June 2021 may leak, giving wrong tidal volumes.
FDA record
Z-0411-20192018-09-27
PSVPro did not transition to SIMV PCV backup on upgraded units.
FDA record
Z-1526-20102010-03-12
Defective control board wiring harness lot could shut the machine down, stopping ventilation and agent.
FDA record

Safety

Safety warnings from the record.

In Alternate O2 control agent delivery stops; without clinician intervention the patient may have a decreased anaesthetic effect. Source
On Aisys CS2 and upgraded Aisys, a brief self correcting agent bolus could occur when using 21% oxygen (2016). Source
PSVPro on some upgraded units did not fall back to SIMV PCV backup ventilation as designed (2018). Source
PCV-VG on Aisys and Avance machines could over deliver volume in certain conditions (2013). Source

Sources

Where this note comes from.

Not covered: The Aisys CS2 user and technical reference manuals were not read, so setting ranges, battery time, weight and the numbered alarm list are not included. More than 20 recall events exist for the Aisys family since 2006; the most relevant are listed. Some recalls cover several GE machines (Avance, Aespire, Amingo) as well.

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.

Anaesthesia Machine