Flow-i C30 Anesthesia System 6888530Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07325710010624), received between May 25, 2022 and Oct 24, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2025Increase in Pressure; Increase in Pressure

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

  Patient problems: Low Oxygen Saturation

  MAUDE report 23384440 ↗
• InjuryOct 24, 2025Increase in Pressure; Increase in Pressure

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

  Patient problems: Low Oxygen Saturation

  MAUDE report 23379131 ↗
• MalfunctionSep 11, 2025Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024321 ↗
• MalfunctionAug 5, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711043 ↗
• MalfunctionJul 3, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE ANESTHESIA SYSTEM WAS UNABLE TO MAINTAIN THE SET PEEP LEVEL. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392605 ↗
• InjuryFeb 18, 2025Output Problem; Output Problem

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

  Patient problems: Low Oxygen Saturation

  MAUDE report 21400099 ↗
• InjuryFeb 18, 2025Output Problem; Output Problem

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

  Patient problems: Low Oxygen Saturation

  MAUDE report 21393896 ↗
• MalfunctionNov 20, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732252 ↗
• MalfunctionOct 12, 2023Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926985 ↗
• MalfunctionAug 8, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE VENTILATION STOPPED DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17478677 ↗
• MalfunctionJun 5, 2023Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057910 ↗
• MalfunctionOct 14, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION SHOWS LOW TIDAL VOLUME AND LOW EXHALATION CO2 CONCENTRATION. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606158 ↗
• MalfunctionMay 25, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION GENERATED ALARM FOR REGULATION PRESSURE LIMITED DURING TREATMENT. ALARM FOR HIGH AIRWAY PRESSURE WAS ALSO GENERATED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14495569 ↗

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