Flow-e Anesthesia System 6887900Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07325710010457), received between Dec 1, 2022 and May 27, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Output Problem” (13 reports).

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

7 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-0991-2024 · 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-0961-2023 · 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-1279-2022 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA SYSTEM WAS NOT WORKING PROPERLY AND THE FIO2 DROPPED RAPIDLY. THERE WAS ALSO A DROP IN THE PATIENT'S SATURATION LEVEL. THE USER SWITCHED TO THE BUILT-IN EMERGENCY VENTILATION WHICH RESOLVED THE ISSUE. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: Low Oxygen Saturation

  MAUDE report 25301408 ↗
• InjuryMay 27, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA SYSTEM WAS NOT WORKING PROPERLY AND THE FIO2 DROPPED RAPIDLY. THERE WAS ALSO A DROP IN THE PATIENT'S SATURATION LEVEL. THE USER SWITCHED TO THE BUILT-IN EMERGENCY VENTILATION WHICH RESOLVED THE ISSUE. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: Low Oxygen Saturation

  MAUDE report 25296329 ↗
• MalfunctionFeb 25, 2026Inaccurate Delivery

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED TO DELIVER FRESH GAS FLOW TO THE PATIENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441884 ↗
• MalfunctionJan 21, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127792 ↗
• MalfunctionOct 24, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376740 ↗
• MalfunctionJul 10, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING AIRWAY PRESSURE SENSOR ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469801 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FIXING SCREW THAT HOLDS THE MONITOR IN PLACE CAME LOOSE AND THE MONITOR FELL OFF FROM THE ANESTHESIA SYSTEM. THIS OCCURRED DURING A ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469794 ↗
• MalfunctionJan 29, 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 #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263116 ↗
• MalfunctionNov 6, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT THE MEASURED PEEP (POSITIVE END EXPIRATORY PRESSURE) WAS HIGHER THAN SET. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619857 ↗
• MalfunctionOct 28, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547091 ↗
• MalfunctionOct 28, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547028 ↗
• MalfunctionSep 5, 2024Output 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 #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144588 ↗
• MalfunctionAug 5, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905326 ↗
• MalfunctionApr 29, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199709 ↗
• MalfunctionMar 5, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835472 ↗
• MalfunctionFeb 26, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775915 ↗
• MalfunctionMay 16, 2023Fracture; Suction Problem; Fracture; Suction Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937193 ↗
• MalfunctionMar 22, 2023Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION GENERATED ALARM INDICATING AN OCCLUSION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589671 ↗
• MalfunctionDec 1, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE O2 FLUSH TEST AND THE AFGO (ADDITIONAL FRESH GAS OUTLET) 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 15898123 ↗

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-0960-2023 · Dec 22, 2022 · Open, Classified
  Getinge Flow-c Anesthesia System, Part No. 6887700
• 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-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
• 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