Aisys CS2Recalls & reported problems

Datex-Ohmeda Inc · AISYS CS2 · Class 2

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Datex-Ohmeda Aisys CS2 is an anesthesia machine that delivers gases and oxygen during surgery. Its 2,055 adverse event reports mostly describe insufficient gas flow, output failures and mechanical problems. The reports include no deaths and 17 injuries. There are 5 recalls, 4 of them open, covering an automatic switch to full oxygen delivery, a breathing circuit hose connected to the wrong port, and a cracked base that could tip.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 2,048
Deaths reported: 0
Injuries reported: 17
Recalls naming it: 5

Summary

The FDA's MAUDE database contains 2,048 adverse event reports that list this exact device (DI 00840682102292), received between Feb 8, 2018 and Sep 30, 2026 — classified as 17 injuries, 2,031 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (527 reports).

5 FDA recall records name this device's identifier, 4 still open.

25 other recalls cover devices cleared under the same FDA submission (K132530, K170872, K172045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jul 30, 2026Open, Classified
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.
Z-3189-2026 · Root cause: Nonconforming Material/Component · FDA record ↗
Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0082-2025 · Root cause: Device Design · FDA record ↗
Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0081-2025 · Root cause: Device Design · FDA record ↗
Jun 1, 2022Terminated
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Z-1389-2022 · Root cause: Process control · FDA record ↗
May 27, 2022Open, Classified
The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.
Z-1427-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Insufficient Flow or Under Infusion527
Therapeutic or Diagnostic Output Failure279
Mechanical Problem275
Electrical /Electronic Property Problem141
Unexpected Therapeutic Results134
Power Problem114
Failure to Run on Battery106
Gas/Air Leak79

Patient problems

No Clinical Signs, Symptoms or Conditions1,955
No Patient Involvement44
No Known Impact Or Consequence To Patient18
No Consequences Or Impact To Patient14
Low Oxygen Saturation8
Cardiac Arrest3
Insufficient Information3
Burn(s)1

Recent adverse event reports

The 25 most recent of 2,048 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949938 ↗
MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949909 ↗
MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948890 ↗
MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946774 ↗
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945096 ↗
MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in insufficient oxygen during a case. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943852 ↗
MalfunctionSep 29, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940226 ↗
MalfunctionSep 29, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933124 ↗
MalfunctionSep 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926633 ↗
MalfunctionSep 28, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926568 ↗
MalfunctionSep 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918739 ↗
MalfunctionSep 25, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906256 ↗
MalfunctionSep 25, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905911 ↗
MalfunctionSep 25, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905814 ↗
MalfunctionSep 25, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905292 ↗
MalfunctionSep 25, 2026Increase in Pressure
It was reported that there was a malfunction during a case resulting in over delivery of pressure. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898745 ↗
MalfunctionSep 24, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889100 ↗
MalfunctionSep 24, 2026Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889053 ↗
MalfunctionSep 24, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883055 ↗
MalfunctionSep 24, 2026Mechanical Problem
It was reported that there was a malfunction during a case resulting ininability to switch ventilation modes as expected. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882067 ↗
MalfunctionSep 24, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was a malfunction resulting in an error that results in an inability to initiate mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881372 ↗
MalfunctionSep 17, 2026No Flow
It was reported that there was a malfunction during pre-use checkout resulting in O2 failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803147 ↗
MalfunctionAug 25, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was a malfunction resulting in loss of ventilation during service. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50428548 ↗
MalfunctionJul 31, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098744 ↗
MalfunctionJul 27, 2026Unexpected Therapeutic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132530, K170872, K172045. One submission often covers many models, so check the product and lot details in each record.

Z-3190-2026 · Jul 30, 2026 · Open, Classified
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Z-3192-2026 · Jul 30, 2026 · Open, Classified
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000
Z-3191-2026 · Jul 30, 2026 · Open, Classified
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Z-0076-2025 · Jul 12, 2024 · Open, Classified
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals
Z-0080-2025 · Jul 12, 2024 · Open, Classified
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by me
Z-0084-2025 · Jul 12, 2024 · Open, Classified
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, howev
Z-0078-2025 · Jul 12, 2024 · Open, Classified
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals traine
Z-0077-2025 · Jul 12, 2024 · Open, Classified
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals
Z-0075-2025 · Jul 12, 2024 · Open, Classified
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals t
Z-0074-2025 · Jul 12, 2024 · Open, Classified
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory suppo
Z-1285-2022 · Apr 25, 2022 · Open, Classified
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Z-1286-2022 · Apr 25, 2022 · Open, Classified
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Z-2596-2021 · Aug 2, 2021 · Open, Classified
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Care
Z-2595-2021 · Aug 2, 2021 · Open, Classified
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW
Z-0313-2021 · Sep 17, 2020 · Open, Classified
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, ped

…and 10 more.

Device details

UDI-DI	`00840682102292`
Brand	Aisys
Model	CS2
Company	Datex-Ohmeda Inc
Product code	BSZ · Gas-machine, anesthesia
Class	Class 2
FDA submission	K132530, K170872, K172045
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 12, 2022

Device type (GMDN): Anaesthesia workstation, general-purpose

An assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.