Aespire ViewRecalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00840682102285), received between Feb 1, 2018 and Sep 28, 2026 — classified as 158 malfunctions.

The most frequently reported specific device problem is “Failure to Run on Battery” (27 reports).

1 FDA recall record name this device's identifier, 1 still open.

23 other recalls cover devices cleared under the same FDA submission (K143530, 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-0077-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914506 ↗
• MalfunctionSep 24, 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 50881414 ↗
• MalfunctionJul 27, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034446 ↗
• MalfunctionJun 24, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL POWER FAILURE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607342 ↗
• MalfunctionJun 10, 2026Increase in Pressure

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING A CASE RESULTING IN PROLONGED EXCESSIVE PRESSURE DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458566 ↗
• MalfunctionMay 22, 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 25260474 ↗
• MalfunctionMay 8, 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 25124869 ↗
• MalfunctionMay 4, 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 25073834 ↗
• MalfunctionMay 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN OVER DELIVERY OF TIDAL VOLUME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058399 ↗
• MalfunctionApr 16, 2026Therapeutic or Diagnostic Output Failure

  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 24900078 ↗
• MalfunctionApr 9, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS AN ERROR CAUSING 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 24826933 ↗
• MalfunctionApr 6, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LOSS OF MANUAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793576 ↗
• MalfunctionApr 2, 2026Increase in Pressure

  IT WAS REPORTED THAT THERE WAS AN ERROR DURING PRE-USE CHECKOUT RESULTING IN POTENTIAL OVER DELIVERY OF PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766869 ↗
• MalfunctionMar 26, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN POTENTIAL LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698059 ↗
• MalfunctionMar 26, 2026Power Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698055 ↗
• MalfunctionMar 25, 2026Mechanical Problem

  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 24687564 ↗
• MalfunctionMar 11, 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 24571408 ↗
• MalfunctionFeb 11, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS AN ERROR RESULTING IN POTENTIAL LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314791 ↗
• MalfunctionFeb 3, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246436 ↗
• MalfunctionFeb 2, 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 24234426 ↗
• MalfunctionJan 26, 2026Unexpected Therapeutic Results

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180143 ↗
• MalfunctionJan 16, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093615 ↗
• MalfunctionDec 22, 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 23872276 ↗
• MalfunctionDec 17, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THERE WAS AN ERROR RESULTING IN A LOSS OF MECHANICAL VENTILATION DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832753 ↗
• MalfunctionDec 9, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF VENTILATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756451 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143530, 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-3189-2026 · Jul 30, 2026 · Open, Classified
  Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
• Z-3191-2026 · Jul 30, 2026 · Open, Classified
  Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
• 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-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-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-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-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-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-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-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

…and 8 more.