Flow-i C20 Anesthesia System 6888520Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 07325710010617), received between Dec 16, 2021 and May 13, 2026 — classified as 2 deaths, 5 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Output Problem” (77 reports).

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

10 other recalls cover devices cleared under the same FDA submission (K191027); 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 18, 2026.

Recalls naming this device

1. Jun 24, 2026Class IIOpen, Classified

   Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

   Z-2860-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Output Problem

  IT WAS REPORTED THAT THE WHILE IN USE ON A PATIENT, THERE WERE DIFFICULTIES WITH PROVIDING GAS TO THE PATIENT. AN ALARM FOR HIGH AIRWAY PRESSURE WAS TRIGGERED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159814 ↗
• DeathApr 30, 2026Output Problem

  IT WAS REPORTED THAT DURING START OF TREATMENT, THE ANESTHESIA SYSTEM STOPPED WORKING. THE EMERGENCY VENTILATION WAS NOT FUNCTIONING EITHER ACCORDING TO THE USER. THE PATIENT PASSED AWAY. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 25044441 ↗
• DeathApr 30, 2026Output Problem

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 25039054 ↗
• MalfunctionApr 1, 2026Failure of Device to Self-Test

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT (SCO). THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750984 ↗
• InjuryMar 25, 2026Failure to Deliver

  IT WAS REPORTED THAT WHEN THE PATIENT WAS CONNECTED TO THE ANESTHESIA SYSTEM AFTER INDUCTION AND MECHANICAL VENTILATION WAS STARTED, NO CHEST EXPANSION PERFORMED. THE PATIENT'S MEASURED SATURATION LEVEL DECREASED TO APPROXIMATELY 50 %. THE PATIENT WAS DISCONNECTED FROM THE SYSTEM AND MANUALLY VENTILATED WITH A BAG-VALVE-MASK AND THE PATIENT SATURATION LEVEL BECAME NORMALIZED WITHIN TWO MINUTES. THE PATIENT FINAL OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Low Oxygen Saturation

  MAUDE report 24687535 ↗
• MalfunctionMar 19, 2026Failure to Power Up

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM DID NOT START. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636297 ↗
• MalfunctionFeb 4, 2026Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING AN OPEN SAFETY VALVE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255804 ↗
• MalfunctionJan 27, 2026Failure of Device to Self-Test; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187805 ↗
• MalfunctionJan 27, 2026Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING THAT THE SAFETY VALVE WAS OPEN WHEN SUPPOSED TO BE CLOSED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187723 ↗
• MalfunctionDec 23, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876057 ↗
• MalfunctionDec 10, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768288 ↗
• MalfunctionDec 5, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING SAFETY VALVE OPEN. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726476 ↗
• MalfunctionDec 1, 2025Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING VENTILATION CONTROL ERROR. IN THE SYSTEM CHECKOUT PERFORMED AFTER THE EVENT THE PRESSURE TRANSDUCER TEST FAILED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680222 ↗
• MalfunctionNov 26, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654361 ↗
• MalfunctionNov 25, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643756 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630168 ↗
• MalfunctionNov 18, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580067 ↗
• MalfunctionOct 31, 2025Increase in Pressure; Output Problem; Increase in Pressure; Output Problem

  IT WAS REPORTED THAT THE FLOW SENSORS WERE NOT DETECTING PRESSURES. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434093 ↗
• MalfunctionOct 21, 2025Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345182 ↗
• MalfunctionSep 10, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE AUTOMATIC VENTILATION PARAMETERS SUDDENLY DISAPPEARED, AND NO VALUES WERE DISPLAYED ON THE INTERFACE. THE END USER IMMEDIATELY ATTEMPTED TO SWITCH TO MANUAL VENTILATION MODE, BUT MANUAL VENTILATION WAS ALSO NON-FUNCTIONAL. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014524 ↗
• MalfunctionSep 8, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM HAD A LEAKAGE. THERE IS NO INFORMATION WHETHER THE EVENT OCCURRED DURING SYSTEM CHECKOUT OR DURING PATIENT TREATMENT. NO PATIENT HARM WAS REPORTED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989921 ↗
• MalfunctionAug 18, 2025Electrical /Electronic Property Problem; Output Problem; Electrical /Electronic Property Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824742 ↗
• MalfunctionAug 1, 2025Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685118 ↗
• MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE VAPORIZER CONNECTION SEAL ON THE ANESTHESIA SYSTEM FELL OF DURING THE DAILY ROUTINE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540040 ↗
• MalfunctionJul 11, 2025Grounding Malfunction; Grounding Malfunction

  MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476802 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191027. One submission often covers many models, so check the product and lot details in each record.

• Z-1074-2025 · Jan 15, 2025 · Open, Classified
  Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
• Z-1877-2024 · May 1, 2024 · Open, Classified
  Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
• Z-0959-2023 · Dec 22, 2022 · Open, Classified
  Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
• Z-0961-2023 · Dec 22, 2022 · Open, Classified
  Getinge Flow-e Anesthesia System, Part No. 6887900
• Z-0960-2023 · Dec 22, 2022 · Open, Classified
  Getinge Flow-c Anesthesia System, Part No. 6887700
• Z-0422-2023 · Nov 7, 2022 · Open, Classified
  Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
• Z-1278-2022 · May 2, 2022 · Terminated
  Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
• Z-1279-2022 · May 2, 2022 · Terminated
  Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
• Z-0468-2022 · Dec 9, 2021 · Open, Classified
  Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthe
• Z-1181-2021 · Jan 29, 2021 · Terminated
  Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in