Aespire 7900Recalls & reported problems

Datex-Ohmeda Inc · AESPIRE 7900 · Class 2

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

Quick summary

This Datex-Ohmeda Aespire 7900 anesthesia gas machine delivers breathing gases during surgery. The 46 adverse event reports mostly describe the machine failing to deliver gas or pressure as expected, battery failures during use or service, and problems during pre-use checks. No deaths or injuries are reported. There are 3 open recalls, all from July 2024, over the risk that a breathing circuit limb could be mistakenly plugged into the auxiliary gas outlet.

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: 48
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00840682102261), received between Feb 8, 2018 and Sep 29, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (9 reports).

3 FDA recall records name this device's identifier, 3 still open.

25 other recalls cover devices cleared under the same FDA submission (K050626, K092864, K122445, 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 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-0074-2025 · 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-0076-2025 · 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-0075-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

Therapeutic or Diagnostic Output Failure9
Failure to Run on Battery7
Mechanical Problem7
Insufficient Flow or Under Infusion6
Unexpected Therapeutic Results4
Electrical /Electronic Property Problem3
Gas/Air Leak3
Increase in Pressure3

Patient problems

No Clinical Signs, Symptoms or Conditions45
No Known Impact Or Consequence To Patient2
No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928101 ↗
MalfunctionSep 25, 2026Mechanical Problem
It was reported that there was a malfunction during a case resulting inloss of ventilation. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900415 ↗
MalfunctionSep 8, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675151 ↗
MalfunctionJul 1, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679677 ↗
MalfunctionJun 3, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372994 ↗
MalfunctionMay 6, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN INABILITY TO SWITCH VENTILATION MODES AS EXPECTED DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092535 ↗
MalfunctionApr 1, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752943 ↗
MalfunctionMar 24, 2026Increase in Pressure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN OVER-DELIVERY OF PRESSURE DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679716 ↗
MalfunctionMar 20, 2026Increase in Pressure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OVER DELIVERY OF PRESSURE DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650816 ↗
MalfunctionMar 20, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A BATTERY FAILURE THAT COULD RESULT IN A LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649174 ↗
MalfunctionMar 12, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580804 ↗
MalfunctionMar 11, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566421 ↗
MalfunctionJan 28, 2026Gas/Air Leak
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK GREATER THAN 4.5 LPM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199828 ↗
MalfunctionJan 27, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24186490 ↗
MalfunctionJan 16, 2026Electrical /Electronic Property Problem; Improper Flow or Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101352 ↗
MalfunctionJan 7, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A POTENTIAL IMPACT TO THE DELIVERY OF O2 OR FRESH GAS FLOW DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988805 ↗
MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659082 ↗
MalfunctionNov 21, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN OR FRESH GAS FLOW DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621004 ↗
MalfunctionNov 4, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468076 ↗
MalfunctionSep 19, 2025Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095818 ↗
MalfunctionAug 29, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928375 ↗
MalfunctionAug 1, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OVER DELIVERY OF PRESSURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687817 ↗
MalfunctionJul 21, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN LOSS OF MECHANICAL VENTILATION DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555248 ↗
MalfunctionJul 16, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521808 ↗
MalfunctionJul 8, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434686 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050626, K092864, K122445, K172045. One submission often covers many models, so check the product and lot details in each record.

Z-3189-2026 · Jul 30, 2026 · Open, Classified
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
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-3190-2026 · Jul 30, 2026 · Open, Classified
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
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-0081-2025 · Jul 12, 2024 · Open, Classified
Aisys. 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 trained
Z-0082-2025 · Jul 12, 2024 · Open, Classified
Aisys CS2. 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 tra
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-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-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-1389-2022 · Jun 1, 2022 · Terminated
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Z-1427-2022 · May 27, 2022 · Open, Classified
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
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-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

…and 10 more.

Device details

UDI-DI	`00840682102261`
Brand	Aespire
Model	7900
Company	Datex-Ohmeda Inc
Product code	BSZ · Gas-machine, anesthesia
Class	Class 2
FDA submission	K050626, K092864, K122445, K172045
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	May 16, 2025

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).

Other Gas-machine, anesthesia devices

Carestation 650 A1
Datex-Ohmeda Inc · Gas-machine, anesthesia
2 recalls3,109 reports
Carestation 750 A1
Datex-Ohmeda Inc · Gas-machine, anesthesia
2 recalls2,204 reports
Aisys CS2
Datex-Ohmeda Inc · Gas-machine, anesthesia
5 recalls2,048 reports
Carestation 620 A1
Datex-Ohmeda Inc · Gas-machine, anesthesia
2 recalls2,015 reports
Avance CS2
Datex-Ohmeda Inc · Gas-machine, anesthesia
6 recalls1,540 reports
Flow-c Anesthesia System 6887700
Maquet Critical Care AB · Gas-Machine, Anesthesia
6 recalls72 reports
FLOW-i C20 6677200
Maquet Critical Care AB · Gas-Machine, Anesthesia
4 recalls99 reports
Flow-e Anesthesia System 6887900
Maquet Critical Care AB · Gas-Machine, Anesthesia
5 recalls19 reports

All Gas-machine, anesthesia devices →

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