Aestiva MRIRecalls & reported problems
Datex-Ohmeda Inc · AESTIVA MRI · Class 2
Quick summary
This Aestiva MRI anesthesia machine supplies gas and breathing support during surgery. Many reports describe power problems, including failure to power up or run on battery, and some describe insufficient gas delivery or loss of mechanical ventilation, often found during pre-use checks. The 158 reports include no deaths and no injuries. No recalls name this device.
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
- 157
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00840682102339), received between Apr 2, 2019 and Sep 30, 2026 — classified as 157 malfunctions.
The most frequently reported specific device problem is “Power Problem” (33 reports).
26 other recalls cover devices cleared under the same FDA submission (K050055, K172045, K993410); 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
Most reported problems
Device problems
- Power Problem33
- Insufficient Flow or Under Infusion21
- Mechanical Problem20
- Therapeutic or Diagnostic Output Failure16
- Failure to Power Up15
- Failure to Run on Battery12
- Infusion or Flow Problem9
- Gas/Air Leak7
Patient problems
- No Clinical Signs, Symptoms or Conditions153
- No Patient Involvement4
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952245 ↗MalfunctionSep 24, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in a leak that could cause insufficient O2. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881084 ↗MalfunctionSep 1, 2026Tidal Volume Fluctuations
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548708 ↗MalfunctionJun 23, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN INSUFFICIENT O2. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598598 ↗MalfunctionJun 19, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF POWER AND SUBSEQUENT LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565226 ↗MalfunctionJun 9, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY DURING PRE-USE CHECKOUT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450361 ↗MalfunctionMay 27, 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 25301488 ↗MalfunctionMay 22, 2026Failure to Power Up
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN THE DEVICE COULDN¿T POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257047 ↗MalfunctionMay 21, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250501 ↗MalfunctionMay 21, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN MIXER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250494 ↗MalfunctionMay 21, 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 25241506 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK DURING PRE-USE CHECKOUT . THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231130 ↗MalfunctionMay 18, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN LOSS OF VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202726 ↗MalfunctionMay 15, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN MACHINE POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182527 ↗MalfunctionMay 15, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT O2 DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25181156 ↗MalfunctionApr 29, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035814 ↗MalfunctionApr 9, 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 24827018 ↗MalfunctionApr 9, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DUE TO FAULTY POWER CORD 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 24825312 ↗MalfunctionMar 30, 2026Insufficient 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 24728572 ↗MalfunctionMar 26, 2026Excess Flow or Over-Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN DELIVERY OF HIGH N20 DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700767 ↗MalfunctionMar 20, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT O2 DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24648471 ↗MalfunctionMar 13, 2026Failure to Power Up
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INABILITY OF UNIT TO POWER UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589829 ↗MalfunctionMar 11, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT O2 DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568133 ↗MalfunctionMar 9, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551595 ↗MalfunctionMar 3, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN STANDBY SWITCH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497938 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K050055, K172045, K993410. One submission often covers many models, so check the product and lot details in each record.
- Z-3190-2026 · Jul 30, 2026 · Open, ClassifiedAisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- Z-3192-2026 · Jul 30, 2026 · Open, ClassifiedEt 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, ClassifiedAisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- Z-3189-2026 · Jul 30, 2026 · Open, ClassifiedAisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- Z-0074-2025 · Jul 12, 2024 · Open, ClassifiedAespire 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-0077-2025 · Jul 12, 2024 · Open, ClassifiedAespire 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-0076-2025 · Jul 12, 2024 · Open, ClassifiedAespire 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-0084-2025 · Jul 12, 2024 · Open, ClassifiedAuxiliary 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-0080-2025 · Jul 12, 2024 · Open, ClassifiedAvance 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-0078-2025 · Jul 12, 2024 · Open, ClassifiedAvance. 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-0075-2025 · Jul 12, 2024 · Open, ClassifiedAespire 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-0081-2025 · Jul 12, 2024 · Open, ClassifiedAisys. 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, ClassifiedAisys 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-1389-2022 · Jun 1, 2022 · TerminatedGE 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, ClassifiedGE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
…and 11 more.
Other Gas-machine, anesthesia devices
- Carestation 650 A1Datex-Ohmeda Inc · Gas-machine, anesthesia2 recalls3,109 reports
- Carestation 750 A1Datex-Ohmeda Inc · Gas-machine, anesthesia2 recalls2,204 reports
- Aisys CS2Datex-Ohmeda Inc · Gas-machine, anesthesia5 recalls2,048 reports
- Carestation 620 A1Datex-Ohmeda Inc · Gas-machine, anesthesia2 recalls2,015 reports
- Avance CS2Datex-Ohmeda Inc · Gas-machine, anesthesia6 recalls1,540 reports
- Flow-c Anesthesia System 6887700Maquet Critical Care AB · Gas-Machine, Anesthesia6 recalls72 reports
- FLOW-i C20 6677200Maquet Critical Care AB · Gas-Machine, Anesthesia4 recalls99 reports
- Flow-e Anesthesia System 6887900Maquet Critical Care AB · Gas-Machine, Anesthesia5 recalls19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.