Flow-c Anesthesia System 6887700Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 07325710009765), received between Jun 14, 2021 and May 8, 2026 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Output Problem” (58 reports).

6 FDA recall records name this device's identifier, 4 still open.

6 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 24, 2026Open, 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 · FDA record ↗

2. Dec 11, 2023Open, Classified

   Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

   Z-0990-2024 · Root cause: Software design · FDA record ↗

3. Dec 22, 2022Open, Classified

   Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

   Z-0960-2023 · Root cause: Software Design Change · FDA record ↗

4. Nov 7, 2022Open, Classified

   The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power failure. This could require the clinician to use manual emergency ventilation of another ventilator is not available and the backup battery is exhausted.

   Z-0422-2023 · Root cause: Component design/selection · FDA record ↗

5. May 2, 2022Terminated

   Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

   Z-1278-2022 · Root cause: Component design/selection · FDA record ↗

6. Jan 29, 2021Terminated

   Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.

   Z-1181-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Failure of Device to Self-Test

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED THE PRESSURE TRANSDUCER TEST DUE TO A TOO HIGH ZERO PRESSURE OFFSET. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122212 ↗
• MalfunctionMar 19, 2026Failure of Device to Self-Test

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637919 ↗
• MalfunctionFeb 20, 2026Output Problem

  IT WAS REPORTED THAT THERE WAS A LEAKAGE DURING PATIENT TREATMENT. THE ANESTHESIA SYSTEM ALSO GENERATED ALARMS FOR HIGH AIRWAY PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399784 ↗
• MalfunctionFeb 11, 2026Output Problem

  IT WAS REPORTED THAT THE ON/OFF SWITCH OF THE SUCTION MODULE ON THE ANESTHESIA SYSTEM WAS BROKEN. THE SUCTION MODULE COULD NOT BE TURNED ON, AND THEREFORE, NO VACUUM COULD BE CREATED. THERE IS NO INFORMATION STATING WHETHER A PATIENT WAS CONNECTED TO THE ANESTHESIA SYSTEM OR NOT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312174 ↗
• MalfunctionJan 21, 2026Failure of Device to Self-Test

  IT WAS REPORTED THAT THE SYSTEM CHECKOUT FAILED AND THAT LIQUID HAD ENTERED THE AIR GAS MODULE. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128896 ↗
• MalfunctionDec 22, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861783 ↗
• MalfunctionDec 16, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816528 ↗
• MalfunctionDec 2, 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 23691966 ↗
• MalfunctionNov 14, 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 23552124 ↗
• MalfunctionOct 31, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435324 ↗
• MalfunctionOct 30, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23422051 ↗
• MalfunctionOct 15, 2025Failure to Deliver; Failure to Deliver

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279173 ↗
• MalfunctionAug 12, 2025Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780366 ↗
• MalfunctionAug 1, 2025Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684249 ↗
• MalfunctionJul 30, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662686 ↗
• MalfunctionJul 18, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540158 ↗
• MalfunctionJul 4, 2025Corroded; Output Problem; Corroded; Output Problem

  IT WAS REPORTED THAT THE SEVOFLURANE VAPORIZER IN THE ANESTHESIA WORKSTATION FAILED IN SYSTEM CHECKOUT TEST. THE VAPORIZER IS THE UNIT CONTAINING ANESTHETIC AGENT IN THE ANESTHESIA WORKSTATION. WHEN THE VAPORIZER WAS RECEIVED FOR INVESTIGATION, A YELLOW/BROWN RESIDUE WAS FOUND INSIDE THE VAPORIZER. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402265 ↗
• MalfunctionJul 1, 2025Contamination; Medical Gas Supply Problem; Contamination; Medical Gas Supply Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370209 ↗
• MalfunctionJul 1, 2025Contamination; Medical Gas Supply Problem; Contamination; Medical Gas Supply Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370206 ↗
• MalfunctionJul 1, 2025Contamination; Medical Gas Supply Problem; Contamination; Medical Gas Supply Problem

  DURING THE INSPECTION OF THE ANESTHESIA WORKSTATION IT WAS DISCOVERED THAT THE AIR GAS MODULE WAS CONTAMINATED WITH WATER. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370200 ↗
• MalfunctionJun 30, 2025Contamination; Medical Gas Supply Problem; Contamination; Medical Gas Supply Problem

  DURING THE INSPECTION OF THE ANESTHESIA WORKSTATION IT WAS DISCOVERED THAT THE AIR GAS MODULE WAS CONTAMINATED WITH WATER. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356517 ↗
• MalfunctionJun 25, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326445 ↗
• MalfunctionMay 19, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042555 ↗
• MalfunctionFeb 7, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332315 ↗
• MalfunctionJan 31, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING TREATMENT, THE MEASURED FICO2 LEVEL WAS HIGH DESPITE A HIGH FRESH GAS FLOW. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281186 ↗

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-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 An