Aisys CS2 WITH ET CONTROLRecalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00195278588128), received between Mar 28, 2024 and Sep 30, 2026 — classified as 98 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (26 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K170872); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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-3190-2026 · Root cause: Nonconforming Material/Component · Recall details · 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-0083-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949825 ↗
• MalfunctionSep 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926590 ↗
• MalfunctionSep 28, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918423 ↗
• MalfunctionAug 27, 2026Insufficient Flow or Under Infusion

  It was reported that there was a low-pressure leak test failure resulting in insufficient O2 during pre-use checkout. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479190 ↗
• MalfunctionJun 29, 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 25656887 ↗
• MalfunctionJun 9, 2026Failure to Run on Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448768 ↗
• MalfunctionMay 27, 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 25299483 ↗
• MalfunctionMay 21, 2026Leak/Splash

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOW PRESSURE LEAK TEST FAILURE DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241388 ↗
• MalfunctionMay 21, 2026Leak/Splash

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOW PRESSURE LEAK TEST FAILURE DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241358 ↗
• MalfunctionMay 18, 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 25203044 ↗
• MalfunctionMay 14, 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 25172115 ↗
• MalfunctionMay 11, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AUXILIARY OXYGEN IS UNAVAILABLE OR LOSS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141976 ↗
• MalfunctionApr 28, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN UNEXPECTED THERAPEUTIC SYSTEM PERFORMANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021166 ↗
• MalfunctionApr 21, 2026Leak/Splash; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LARGE LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942660 ↗
• MalfunctionApr 17, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908577 ↗
• MalfunctionApr 15, 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 24889480 ↗
• MalfunctionApr 7, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN PROLONGED INSUFFICIENT OXYGEN (O2) CONCENTRATION OR FRESH GAS FLOW DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802607 ↗
• MalfunctionApr 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DUE TO A LARGE LEAK DURING A CASE. THE UNIT WAS REPLACED AND CASE COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790471 ↗
• MalfunctionMar 26, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A SYSTEM MALFUNCTION DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698280 ↗
• MalfunctionMar 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK 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 24617582 ↗
• MalfunctionMar 12, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SYSTEM SHUTDOWN DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579477 ↗
• MalfunctionMar 10, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY LESS THAT -20% OF SETTING DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558901 ↗
• MalfunctionMar 10, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING SERVICE RESULTING IN INSUFFICIENT OXYGEN (O2) CONCENTRATION OR FRESH GAS FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557653 ↗
• MalfunctionMar 3, 2026No Flow

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF AUXILIARY O2 DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493552 ↗
• MalfunctionFeb 19, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN OR FRESH GAS FLOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388146 ↗

Recalls under the same FDA submission

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

• Z-0412-2019 · Sep 27, 2018 · Terminated
  Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRA
• Z-0413-2019 · Sep 27, 2018 · Terminated
  Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X
• Z-0411-2019 · Sep 27, 2018 · Terminated
  Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE K
• Z-1199-2018 · Oct 4, 2017 · Terminated
  DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.