HAMILTON-MR1Recalls & reported problems across all models

We found 2 models of HAMILTON-MR1 by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2021 and May 4, 2026 — classified as 3 deaths, 1 injury, 145 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (22 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HAMILTON-MR1 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 26, 2023Open, Classified

   Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

   Z-2530-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jul 26, 2023Open, Classified

   Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

   Z-2528-2023 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

Most reported HAMILTON-MR1 problems

HAMILTON-MR1 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HAMILTON-MR1 161010

  Ventilator, Continuous, Facility Use
  2 recalls3 deaths132 reports
• HAMILTON-MR1 1610100

  Ventilator, Continuous, Facility Use
  1 recall19 reports

Recent HAMILTON-MR1 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Activation Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG: "WHEN THE USER ON THE UNIT, "TESLASPY SERVICE REQUIRED" ALARM IS SHOWN". IT WAS REPORTED NO PATIENT INVOLVEMENT. NO HARM TO ANY PATIENT, USER OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067194 ↗
• MalfunctionApr 14, 2026No Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG: ¿FAN FAILURE ALARM BASED ON INFORMATION PROVIDED BY THE HOSPITAL¿S BIOMEDICAL DEPARTMENT, THE DEVICE APPEARS TO HAVE BEEN BROUGHT TOO CLOSE TO THE MRI MAGNETIC FIELD.¿ IT WAS REPORTED THAT NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT OCCURRED. THE DEVICE REMOVED FROM PATIENT AND SENT TO HAMILTON FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877643 ↗
• MalfunctionMar 26, 2026Improper Flow or Infusion

  IT WAS REPORTED TO HAMILTON MEDICAL AG: "EXHALATION OBSTRUCTED, INSPIRATORY VOL. ALARMS. LOW PRESSURE PEEP PROBLEMS, LOW VT, HIGH FREQUENCY". PATIENT WAS INVOLVED. NO INTERVENTION NECESSARILY, NO HEALTH OR CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696443 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: ¿IMMEDIATELY AFTER STARTING VENTILATION, MR1 DISPLAYS THE ERROR MESSAGES ¿EXPIRATORY STENOSIS¿ AND ¿PEEP TOO HIGH.¿ A PATIENT WAS CONNECTED AND DEVICE WAS EXCHANGED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415040 ↗
• MalfunctionDec 12, 2025Failure to Deliver; No Flow; Failure to Deliver; No Flow

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE REMOVING A PATIENT FROM A CT SCAN, THE DEVICE CANCELED VENTILATION, AND THE EVENT LOG RECORDED TECHNICAL FAULTS 446029 (AMBIENT FAILURE DETECTED), 485001 (AMBIENT FAILURE DETECTED) AND 431001 (BLOWER FAULT). THE CUSTOMER ALSO REPORTED THE TESLASPY INDICATOR FLASHED YELLOW DESPITE THE INCIDENT OCCURRING IN A CT ENVIRONMENT (NOT THE MRI SUITE). NO PATIENT HARM WAS REPORTED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786816 ↗
• MalfunctionOct 29, 2025Computer Software Problem; Computer Software Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE LOCAL STAFF WAS CONDUCTING AN OPERATIONAL CHECK OF MR1. WHEN THE POWER TO MR1 WAS TURNED ON, IT SUDDENLY SWITCHED TO SAFETY MODE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411114 ↗
• MalfunctionAug 20, 2025Gas Output Problem; Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE ALARMED WITH LOW OXYGEN. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847839 ↗
• MalfunctionAug 20, 2025Electrical /Electronic Property Problem; Insufficient Device Problem Information; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: QUOTATION FROM THE REPORTER: "THE BLOWER MADULE IS NOT ENERGIZING DURING POST AND THE MR1 KEEPS ALARMING SAYING THE BLOWER IS NOT FUNCTIONING." NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847490 ↗
• MalfunctionJul 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: ACCORDING TO THE COMPLAINT, THE PRETESTS OF THE VENTILATOR PASSED. HOWEVER, WHEN THE VENTILATION WAS INITIATED ON PATIENT, THERE WAS NO VISIBLE SIGN OF CHEST MOVEMENT. RETURN TIDAL VOLUMES WERE 30-50ML WHEN THE VENTILATOR WAS SET AT 400ML. THE VENTILATOR WAS EXCHANGED, AND THE PATIENT HAD NORMAL CHEST MOVEMENT AND RETURN TIDAL VOLUMES WERE CORRECT. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505268 ↗
• MalfunctionMay 23, 2025Insufficient Cooling; Insufficient Cooling

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "FAN FAILURE ALARM". THERE IS PATIENT INVOLVEMENT REPORTED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. THE AVAILABLE INFORMATION REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THERE WE ASSESSED THIS EVENT AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076589 ↗
• MalfunctionApr 30, 2025Defective Component; Defective Component

  DURING PATIENT VENTILATION THE HAMILTON-MR1 VENTILATOR DEVICE ALERTED FOR FAN FAILURE. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE WAS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NO DEVICE LOG FILES WERE PROVIDED TO HAMILTON MEDICAL. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932705 ↗
• MalfunctionApr 23, 2025Insufficient Cooling; Insufficient Cooling

  ¿HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "VENT BEGAN ALARMING FAN FAILURE". THERE IS NO PATIENT INVOLVEMENT. THE DEVICE LOG FILES WHERE NOT PROVIDED TO HAMILTON MEDICAL. IN A WORST-CASE SCENARIO, A FAN FAILURE COULD LEAD TO A DETERIORATION OF THE STATE OF HEALTH OF THE PATIENT. THEREFORE, THIS CASE WAS ASSESSED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889374 ↗
• MalfunctionMar 5, 2025Complete Loss of Power; Complete Loss of Power

  THE (B)(6) DID SUBMIT TO BFARM THE REPORT WITH REFERENCE (B)(4). HAMILTON MEDICAL ENTER THE CASE UNDER THE REFERENCE (B)(4). HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION ¿THE DEVICE SWITCHED ITSELF OFF COMPLETELY. THE LOG FILES SHOW THAT THE DEVICE RAN ON BATTERY POWER UNTIL IT SWITCHED ITSELF OFF¿. THE FIRST ANALYSIS OF THE LOGFILE AS PROVIDED BY THE LOCAL PARTNER SHOWS THAT ALARMS WERE IGNORED. ALARMS SUCH AS ¿LOSS OF EXTERNAL POWER¿ AND ¿BATTERY LOW WARNINGS¿ WERE IGNORED FROM THE MOMENT THAT THE DEVICE WAS STARTED UP ON REPORTED DAY (B)(6) 2025. DEVICE STARTED AT 14:50:49 AND THE DEVICE REPORTED A LOSS OF EXTERNAL POWER AT 14:51:00. AT 14:51:01, THE DEVICE REPORTED A HIGH-PRIORITY BATTERY LOW ALARM, WHICH WAS RESET AT 14:51:03. THE DEVICE REPEATEDLY ALERTED WITH BATTERY LOW UNTIL IT SWITCHED TO AMBIENT STATUS AT 15:36:50 AND SHUT ITSELF OFF AT 16:53:43. THE EXACT TIME OF THE MRI EXAMINATION OF THE AFFECTED PATIENT IS UNKNOWN. THE OPERATOR MANUAL FOR THE HAMILTON-MR1 CLEARLY STATES THAT THE DEVICE SHOULD BE CONNECTED TO THE PRIMARY POWER SOURCE. THE BATTERIES ARE FOR BACKUP. ALSO, THE BATTERIES LEVELS NEED TO BE CHECKED BEFORE USAGES. STARTING WITH A FLAT BATT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523867 ↗
• MalfunctionFeb 26, 2025Gas Output Problem; Gas Output Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE VENTILATOR DEVICE ALERTS FOR LOW O2. IN USER MODE THE O2 SET VALUE COULD NOT BE REACHED OR IT TAKES TO LONG BEFORE REACHING IT. THERE IS PATIENT INVOLVEMENT REPORTED BUT IS NOT FURTHER SPECIFIED. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. WORST CASE, A LOW O2 FLOW COULD LEAD TO SEVERE DESATURATION (SPO2 <80%).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468124 ↗
• MalfunctionFeb 21, 2025Insufficient Cooling; Electrical /Electronic Property Problem; Insufficient Cooling; Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE VENTILATOR DEVICE FAILED FOR THE CHECK VALVE AND LEAK TESTS. THE FAN IS DEFECTIVE". THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. WHEN A VENTILATOR DEVICE DOESN¿T START-UP THAT COULD LEAD TO DESATURATION (SPO2 80-87%) WHAT MAKES THIS CASE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431870 ↗

Other Hamilton Medical AG products

• HAMILTON-C12 models · 2,012 reports · 2 recalls
• HAMILTON-G52 models · 1,891 reports
• HAMILTON-T15 models · 1,185 reports · 3 recalls
• HAMILTON-C22 models · 853 reports · 1 recall
• Breathing circuit set, coaxial4 models · 24 reports · 2 recalls