Fabius MRI 8607300Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04048675041498), received between Jul 24, 2020 and Oct 22, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (15 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K072884); 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. Dec 16, 2021Terminated

   26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.

   Z-0501-2022 · Root cause: Process control · 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.

• MalfunctionOct 22, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE O2 CENTRE SENSOR FAILED AND A VENTILATOR FAILURE OCCURED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355719 ↗
• MalfunctionMay 8, 2025Failure to Deliver; Insufficient Device Problem Information; Failure to Deliver; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FABIUS MRI REBOOTED 3 TIMES DURING VENTILATION WHEN THE RADIOLOGIST STARTING SCANNING THE PATIENT. THE DEVICE WAS WELL BEHIND THE MARKED LINE ON THE FLOOR AND NO ALARMS INDICATED THAT THE DEVICE WAS TOO CLOSE TO THE MAGNET. THE SCREEN WENT BLACK WITH THE COMMAND TEXT VISIBLE ON THE SCREEN, VENTILATION WAS CEASED AND THIS REOCCURRED A FURTHER TWO TIMES BEFORE SCANNING WAS CEASED AND THE DEVICE WAS PULLED OUT OF THE ROOM. THE ANESTHETIST CONTINUED THE CASE WITH THE MACHINE POSITIONED OUTSIDE OF THE MRI ROOM FOLLOWING A SYSTEM TEST WAS INDICATED THE MACHINE WAS FUNCTIONAL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983400 ↗
• MalfunctionJan 9, 2025Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver; Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE ALARMED ¿VENTILATOR FAILURE¿ ON A PATIENT DURING PRESSURE CONTROL. PATIENT COULD BE VENTILATED MANUALLY BY ANAESTHETIST INSIDE MRI SCANNER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109143 ↗
• MalfunctionJan 9, 2025Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver; Gas Output Problem; Incorrect Interpretation of Signal; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE ALARMED ¿VENTILATOR FAILURE¿ ON A PATIENT DURING PRESSURE SUPPORT. PATIENT WAS ABLE TO BE VENTILATED ON MAN/SPONT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21109087 ↗
• MalfunctionOct 11, 2024Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE FABIUS HAD A VENTILATOR FAILURE, NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426235 ↗
• MalfunctionSep 9, 2024Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO VENTILATE DURING A PROCEDURE AND A "VENTILATION FAILURE" MESSAGE WAS DISPLAYED ON THE SCREEN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168843 ↗
• MalfunctionAug 1, 2024Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  IT WAS REPORTED THAT THE VENTILATOR SOUNDS LOUDER THAN NORMAL. BASED ON THE LOG ANALYSIS A VENTILATOR FAILURE OCCURRED DUE TO A NEGATIVE AIRWAY PRESSURE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19881731 ↗
• MalfunctionAug 1, 2024Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO VENTILATE DURING A PROCEDURE AND A "VENTILATION FAILURE" MESSAGE WAS DISPLAYED ON THE SCREEN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19881730 ↗
• MalfunctionApr 26, 2024Use of Device Problem; No Apparent Adverse Event; Use of Device Problem; No Apparent Adverse Event

  IT WAS REPORTED THERE WAS A VENTILATOR FAILURE DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19189971 ↗
• MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE MACHINE REBOOTED FIVE TIMES DURING THE CASE AND EACH TIME BOOTED UP TO MAN/SPONT MODE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892676 ↗
• MalfunctionNov 2, 2023Gas Output Problem; Failure to Sense; Failure to Deliver; Power Problem; Gas Output Problem; Failure to Sense; Failure to Deliver; Power Problem

  IT WAS REPORTED THERE WAS A VENT FAIL AND AC FAIL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053615 ↗
• MalfunctionJun 22, 2023Failure to Deliver; Therapeutic or Diagnostic Output Failure; Unexpected Shutdown; Failure to Deliver; Therapeutic or Diagnostic Output Failure; Unexpected Shutdown

  IT WAS REPORTED THE DEVICE REBOOTED DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180323 ↗
• MalfunctionApr 4, 2023Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE VENTILATOR WAS INOP. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16673947 ↗
• InjuryJan 16, 2023Use of Device Problem; Failure to Calibrate; No Apparent Adverse Event; Use of Device Problem; Failure to Calibrate; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT HAD AN ACUTE HYPOXEMIA. RESUSCITATION MANEUVERS WERE PERFORMED. IN CONSEQUENCE A VEGETATIVE STATE WAS REPORTED.

  Patient problems: Altered State of Consciousness; Hypoxia

  MAUDE report 16172959 ↗
• MalfunctionOct 12, 2022Failure to Deliver; Unexpected Shutdown; Failure to Deliver; Unexpected Shutdown

  IT WAS REPORTED DURING A CASE THAT THE UNIT HAD RESTARTED MOMENTARILY AND WENT BACK TO DEFAULT SETTINGS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586001 ↗
• MalfunctionAug 25, 2022Gas Output Problem; Failure to Deliver; Electrical Overstress; Gas Output Problem; Failure to Deliver; Electrical Overstress

  IT WAS REPORTED THAT THE VENTILATOR STOPPED DURING USE OF THE DEVICE. IT WAS MENTIONED THAT NO CONSEQUENCES TO THE PATIENT HAVE RESULTED FROM THAT; PATIENT SUPPORT WAS DONE IN MAUNAL VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291348 ↗
• MalfunctionDec 21, 2021Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051922 ↗
• MalfunctionOct 6, 2021Intermittent Continuity; Gas Output Problem; Failure to Deliver; Intermittent Continuity; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE UNIT RESTARTED MULTIPLE TIMES DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12582050 ↗
• MalfunctionJul 24, 2020Gas Output Problem; Loss of Threshold; Failure to Deliver; Gas Output Problem; Loss of Threshold; Failure to Deliver

  PLEASE REFER TO INITIAL MFR. REPORT #9611500-2020-00259.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319007 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072884. One submission often covers many models, so check the product and lot details in each record.

• Z-2252-2018 · May 24, 2018 · Terminated
  Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O,
• Z-1481-2018 · Mar 1, 2018 · Terminated
  Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be
• Z-2271-2015 · Jun 22, 2015 · Terminated
  Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.