Avance CS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,540 adverse event reports that list this exact device (DI 00840682102322), received between Feb 2, 2018 and Sep 30, 2026 — classified as 5 injuries, 1,535 malfunctions.

The most frequently reported specific device problem is “Failure to Run on Battery” (241 reports).

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

23 other recalls cover devices cleared under the same FDA submission (K123125, K131945, 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.

Recalls naming this device

1. 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-0078-2025 · Root cause: Device Design · FDA record ↗

2. 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-0079-2025 · Root cause: Device Design · FDA record ↗

3. 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-0080-2025 · Root cause: Device Design · FDA record ↗

4. 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 ↗

5. 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 ↗

6. Apr 25, 2022Open, Classified

   Backup batteries can fail earlier than their estimated life.

   Z-1285-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,540 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Power Problem

  It was reported that there was a malfunction during pre-use checkout resulting in power management system failure. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947553 ↗
• MalfunctionSep 30, 2026Failure to Run on Battery

  It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947134 ↗
• MalfunctionSep 29, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941064 ↗
• MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934799 ↗
• MalfunctionSep 29, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933186 ↗
• MalfunctionSep 29, 2026Failure to Run on Battery

  It was reported that there was a loss of mechanical ventilation during a case due to battery failure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931661 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  It was reported that there was a malfunction resulting in 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 50931588 ↗
• MalfunctionSep 29, 2026Insufficient Flow or Under Infusion

  It was reported that there was a error resulting in insufficient O2 during pre-use checkout. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931447 ↗
• MalfunctionSep 28, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926615 ↗
• MalfunctionSep 28, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925973 ↗
• MalfunctionSep 28, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921974 ↗
• MalfunctionSep 25, 2026Failure to Run on Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905984 ↗
• MalfunctionSep 24, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889105 ↗
• MalfunctionSep 17, 2026Failure to Run on Battery

  It was reported that there was a battery failure during service that could cause loss of mechanical ventilation. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806993 ↗
• MalfunctionAug 27, 2026Mechanical Problem

  It was reported that there was a malfunction during pre-use checkout resulting in loss of mechanical ventilation. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473758 ↗
• MalfunctionAug 17, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276220 ↗
• MalfunctionAug 5, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147537 ↗
• MalfunctionAug 5, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143012 ↗
• MalfunctionJul 1, 2026Failure to Charge

  IT WAS REPORTED THAT THERE WAS A FAILURE TO CHARGE THE BATTERY THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678074 ↗
• MalfunctionJul 1, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INABILITY TO SWITCH VENTILATION MODES AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675577 ↗
• MalfunctionJun 30, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN LOSS OF UNIT POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668313 ↗
• MalfunctionJun 30, 2026Failure 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 25668299 ↗
• MalfunctionJun 30, 2026Therapeutic or Diagnostic Output Failure

  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 25664568 ↗
• MalfunctionJun 29, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF POWER AND SUBSEQUENT LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658074 ↗
• MalfunctionJun 29, 2026Increase in Pressure

  IT WAS REPORTED THAT THERE WAS AN MALFUNCTION RESULTING IN OVER DELIVERY OF PRESSURE DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123125, K131945, K172045. One submission often covers many models, so check the product and lot details in each record.

• 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-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-3189-2026 · Jul 30, 2026 · Open, Classified
  Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
• 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-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-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-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-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-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-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-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-0314-2021 · Sep 17, 2020 · Open, Classified
  9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

…and 8 more.