Flow-i C40 Anesthesia System 6888540Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07325710010631), received between Mar 27, 2023 and Jul 1, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Output Problem” (6 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. 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 ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 22370198 ↗
• MalfunctionApr 30, 2025Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THAT WHEN USING THE LASER DURING THE END OF AN ENT SURGERY IN THE PATIENT'S EAR, A FLAME WAS GENERATED CAUSING A BURN IN THE PATIENT EAR. PATIENT FINAL OUTCOME WAS NO INJURY AND NO INTERVENTION REQUIRED. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933485 ↗
• MalfunctionOct 8, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394707 ↗
• MalfunctionMay 23, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE SEVOFLURANE VAPORIZER IN THE ANESTHESIA WORKSTATION FAILED IN SYSTEM CHECKOUT AND GENERATED A TECHNICAL ERROR CODE INDICATING VAPORIZER ERROR. 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 19383116 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS IN USE FOR TREATMENT, THE PATIENT SATURATION DECREASED TO 77 %. THE PATIENT WAS DISCONNECTED FROM THE SYSTEM AND MANUALLY VENTILATED WITH AN AMBU BAG. THE PATIENT RECOVERED AND THE FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Low Oxygen Saturation

  MAUDE report 18632120 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS IN USE FOR TREATMENT, THE PATIENT SATURATION DECREASED TO 77 %. THE PATIENT WAS DISCONNECTED FROM THE SYSTEM AND MANUALLY VENTILATED WITH AN AMBU BAG. THE PATIENT RECOVERED AND THE FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: Low Oxygen Saturation

  MAUDE report 18630705 ↗
• MalfunctionOct 17, 2023Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE ANESTHESIA SYSTEM DID NOT CYCLE PROPERLY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948284 ↗
• MalfunctionOct 2, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED THE LEAKAGE TEST DURING SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: 886275

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851510 ↗
• MalfunctionMar 27, 2023Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620947 ↗

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-0961-2023 · Dec 22, 2022 · Open, Classified
  Getinge Flow-e Anesthesia System, Part No. 6887900
• 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-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 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