HAMILTON-T1Recalls & reported problems across all models

We found 5 models of HAMILTON-T1 by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 1,185 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2021 and Sep 29, 2026 — classified as 10 deaths, 30 injuries, 1,145 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (335 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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-T1 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-2527-2023 · Root cause: Nonconforming Material/Component · names 2 of these models · 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-2526-2023 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

3. Jun 15, 2023Open, Classified

   Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

   Z-2140-2023 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗

Most reported HAMILTON-T1 problems

HAMILTON-T1 models

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

• HAMILTON-T1 161006

  Ventilator, Continuous, Facility Use
  2 recalls1 death471 reports
• HAMILTON-T1 1610090

  Ventilator, Continuous, Facility Use
  2 recalls3 deaths368 reports
• HAMILTON-T1 1610060

  Ventilator, Continuous, Facility Use
  2 recalls3 deaths159 reports
• HAMILTON-T1 161009

  Ventilator, Continuous, Facility Use
  1 recall3 deaths182 reports
• HAMILTON-T1 161005

  Ventilator, Continuous, Facility Use
  5 reports

Recent HAMILTON-T1 adverse event reports

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

• MalfunctionSep 29, 2026Loose or Intermittent Connection

  Hamilton Medial AG received the following complaint description (summary):It was reported that, during transport of an intubated patient to (b)(6) on (b)(6)2026, a HAMILTON-T1 (Product No. 161006, (b)(6), software version not reported) generated an alarm indicating that the oxygen supply was empty approximately 20 minutes before reaching Pori.According to the information provided, the transport had started with a full 10-liter oxygen cylinder. The patient was connected to the ventilator without reported difficulty, and no warnings or abnormal device behavior were reportedly observed before the oxygen supply alarm occurred.The transport stopped at a hospital, where the primary oxygen cylinder was replaced with an available spare cylinder. Ventilation was continued using the same HAMILTON-T1. The complaint records medical intervention as ¿Yes¿ and states that ventilation during transport was completed using the spare oxygen cylinder. No patient, user or third-party harm or adverse clinical outcome was reported.The user reported hearing a leak near the plastic retaining nut securing the return hose. According to the user, the expiratory valve had not been fully tightened, and the repo

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930188 ↗
• MalfunctionSep 29, 2026Inaccurate Delivery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928494 ↗
• MalfunctionSep 25, 2026Inaccurate Delivery

  It was reported to Hamilton Medical AG, that: "SIMV not ventilating patient and showing minimal to none VTE. Complete failure on patient flight. SIMV-TV 450, VTE showed 125 with high PIPs. Pressure mode 18/8, returns low as well because of the lung compliance and unable to ventilate the patient with the vent. He tried smart mode and VTE improved but alerts with "ASV unable to reach limit". Due to the respiratory patient condition, they tried the vent again on a patient without any respiratory issues and had the same failures. We had this same issue with a vent at Delta SN (b)(6) currently being evaluated by your team."Patient involvement, but without patient, user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895312 ↗
• InjurySep 25, 2026No Flow

  Hamilton Medial AG received the following complaint description (summary):It was reported that during patient transport from the ambulance HAMILTON-T1 to the hospital HAMILTON-T1, the user reported that the ventilator was not delivering breaths and that no waveforms or volume/min values were displayed. The patient was manually bagged to facilitate oxygenation. Another ventilator was used. The patient was ventilated in Pressure/SIMV mode on the replacement ventilator.The patient¿s oxygen saturation decreased to 85% and subsequently increased to 93% following manual bagging.Note: Hamilton Medical AG¿s investigation is ongoing to verify the allegation reported in the complaint.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50893915 ↗
• MalfunctionSep 24, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885235 ↗
• MalfunctionSep 17, 2026Circuit Failure

  It was reported to Hamilton Medical AG, that: "INTERMITTENT ISSUES, INCLUDING SPONTANEOUS MODE CHANGE, SCREEN LOCKING UP AND ODD ALARMS (VT, AND MINUTE VOLUME) PER TECH SUPPORT, CHANGE CONTROL BOARD AND PRESSURE SENSOR ASSEMBLY."No patient involvement and no user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803847 ↗
• MalfunctionAug 27, 2026Obstruction of Flow

  Hamilton Medial AG received the following complaint description (summary): It was reported that a HAMILTON-T1 ventilator (Product No. 1610060, S/N (b)(6), SW 3.1.1) repeatedly generated an "Exhalation Obstruction" alarm on (b)(6) 2026 while connected to a CCT (Critical Care Transport) isolette. The issue was reported to have occurred with multiple breathing circuits from different lot numbers, and the most recently affected circuits remained attached to the isolette at the time of reporting. No patient, user, or third-party harm was reported. A medical intervention was indicated; however, no further details were provided. The investigation to verify the allegation is still in progress.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472498 ↗
• MalfunctionJul 3, 2026Excess Flow or Over-Infusion; Tidal Volume Fluctuations

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "DURING CLINICAL USE ON AN INTUBATED PATIENT, A HAMILTON TRANSPORT VENTILATOR INITIALLY FUNCTIONED NORMALLY AND DELIVERED REALISTIC VENTILATION PARAMETERS AFTER ALL REQUIRED PRE-USE CHECKS, INCLUDING CIRCUIT VERIFICATION ACCORDING TO UPDATED INSTRUCTIONS. SUDDENLY DURING PATIENT TREATMENT, THE VENTILATOR BEGAN DELIVERING ABNORMALLY RAPID VENTILATION WITH VERY LOW TIDAL VOLUMES (APPROXIMATELY 60 ML). THIS WAS FOLLOWED BY INTERMITTENT APNEA PERIODS. THE DEVICE THEN CONTINUED ALTERNATING BETWEEN RAPID VENTILATION WITH LOW TIDAL VOLUMES AND PAUSES IN VENTILATION. THE PATIENT WAS IMMEDIATELY SWITCHED TO MANUAL VENTILATION, AND THE VENTILATOR WAS REPLACED WITH ANOTHER HAMILTON DEVICE. THE REPLACEMENT DEVICE FUNCTIONED NORMALLY WITHOUT RECURRENCE OF THE ISSUE. SUBSEQUENT TESTING OF THE AFFECTED VENTILATOR, INCLUDING STANDARD FUNCTIONAL TESTS AND CIRCUIT CHECKS, SHOWED NORMAL PERFORMANCE, AND THE FAULT COULD NOT BE REPRODUCED. THE BREATHING CIRCUIT WAS ALSO REPLACED. ALL VENTILATORS IN THE UNIT HAD RECENTLY UNDERGONE MAINTENANCE." PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION, BUT NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703641 ↗
• MalfunctionJun 26, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (QUOATATION): "CUSTOMER REPORTS MULTIPLE "PATIENT DISCONNECT" ALARMS, WHILE ATTEMPTING TO USE ON PATIENT." PATIENT WAS INVOLVED, PATIENT HAD TO BE BAGGED. NO PATIENT, USER, THIRD PARTY HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633477 ↗
• DeathJun 24, 2026Insufficient Device Problem Information

  UNKNOWN DATE OF DEATH. CUSTOMER STATES VENTILATOR WAS INVOLVED IN A SENTINEL EVENT. T.

  Patient problems: Insufficient Information

  MAUDE report 25616120 ↗
• MalfunctionJun 18, 2026No Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) IS DISPLAYING THE FOLLOWING TECHNICAL FAULTS: BLOWER FAULT, 446029, 485001. THEN VENTILATOR HAS STOPPED WORKING AND DISPLAYING THESE MESSAGES. NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25544703 ↗
• MalfunctionJun 16, 2026Failure to Sense; Pressure Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) EXHIBITED A 231022 ERROR CODE DURING NEO THERAPY. THE EXACT DATE AND TIME OF THE EVENT IS UNKNOWN. THIS IS THE SECOND TIME IN X WEEKS' TIMEFRAME THAT THIS EVENT OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A LOSS OF PRESSURE WHILE RUNNING NCPAP ON A TRANSPORT FLIGHT, WITH THE REPORTED EVENT DATE OF APRIL 26, 2026. MEDICAL INTERVENTION WAS REPORTED, BUT OF UNKNOWN NATURE. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (UNKNOWN NATURE), BUT WITHOUT PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518265 ↗
• MalfunctionJun 16, 2026Inadequate User Interface; No Flow; No Visual Prompts/Feedback

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN: 161006 / SN: (B)(6) FAILED TO VENTILATE DURING USE/WHILST THE STAFF WAS PREPARING THE PATIENT FOR TRANSFER. DISCONNECTED FROM WALL OXYGEN PORT TO ATTACH OXYGEN BOTTLE. THE VENTILATOR STOPPED DELIVERING BREATHS. RE-ATTACHED TO WALL, BUT THE VENTILATOR DID NOT RESTART. WHEN DISCONNECTED CIRCUIT FROM ET TUBE (ENDOTRACHEAL TUBE), NO AIR WAS FLOWING THROUGH THE CIRCUIT. SCREEN FROZEN AND STAFF WAS UNABLE TO CHANGE ANY VALUES. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (CHANGING TO A DIFFERENT HAMILTON-T1 VENTILATOR) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514960 ↗
• MalfunctionJun 12, 2026Failure to Deliver

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE INCIDENT OCCURRED ON THE VENTILATOR WITH FOLLOWING EQUIPMENT DETAILS: SERIAL NO# (B)(6) THE ERROR THAT OCCURRED WAS TECHNICAL EVENT: 232003. THIS ERROR OCCURRED WHILST PROVIDING HIFLOWO2 TO THE PATIENT WITH THE SETTINGS OF A FLOW RATE OF 30L/MIN AND OXYGEN OF 45%. THE ERROR APPEARED AT THE TOP OF THE SCREEN AND MADE A LOUD AUDIBLE WARNING NOISE AND THEN STOPPED PROVIDING OXYGENATION TO THE PATIENT AND WOULD NOT ALLOW ANY PARAMETERS OF THE SETTINGS TO BE ALTERED. THIS HAPPENED ROUGHLY 15-20 MINUTES AFTER STARTING THE HIFLOWO2 TREATMENT TO THE PATIENT. WE THEN TURNED THE VENTILATOR OFF AND TRANSITIONED TO A NON-REBREATHER OXYGEN MASK AND RESTARTED THE VENTILATOR TO TRY AND TROUBLE SHOOT THE ERROR. WE THEN SUBSEQUENTLY PERFORMED A DOPE PROCEDURE ON THE VENTILATOR AND HIFLOWO2 CIRCUIT TO ENSURE THAT THERE WAS NO PROBLEM. THIS "DOPE" PROCEDURE INCLUDED ENSURING THAT THE CIRCUIT AND NASAL PRONGS WEREN'T "D"ISPLACED; THAT THERE WAS NO "O"BSTRUCTION TO THE CIRCUIT OR IN THE PATIENTS NOSE; THAT THE PATIENT DID NOT HAVE A "PNEUMOTHORAX; AND TO CHECK THE "EQUIPMENT. NO HARM OR ADVERSE EVENT OCCURRED TO THE PATIENT AS THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482591 ↗
• InjuryJun 2, 2026Insufficient Flow or Under Infusion

  DURING PATIENT CARE HAMILTON VENTILATOR BEGAN TO ALARM "LOW OXYGEN". O2 SOURCE WAS CHECKED AND CONFIRMED ON PORTABLE O2 TANK. VENTILATOR WAS THEN PLACED ON THE ONBOARD AIRCRAFT OXYGEN SYSTEM, LOW O2 ALARMS CONTINUED. ADDITIONAL PORTABLE TANK ATTEMPTED AND LOW O2 ALARMS PERSISTED. DURING FLIGHT "FAILED O2 SOURCE" ALARM. PATIENT BEGAN TO DESATURATE DURING FLIGHT - THIS WAS AFTER 10 MINS OF CONTINUOUS ALARMS AND TROUBLESHOOTING. PATIENT WAS REMOVED FROM VENT AND BAGGED WITH BVM ON 15LPM. VENT WAS CHECKED - ALL CONNECTIONS, HOSES, O2 SOURCES VERIFIED - OXYGEN TANK FULL. ONBOARD OXYGEN WAS RUNNING- UNABLE TO RESOLVE THE ISSUE. ADDITIONAL INFO PROVIDED: 1.AIRCRAFT O2 INTERFACE/REGULATOR MODEL: ESSEX MEDICAL SYSTEMS PLUS 2. HOSE TYPE, AND INFORMATION ON WHETHER A QUICK-CONNECT WAS USED: HIGH PRESSURE O2 LINE (MEDICAL OXYGEN RESPIRONICS REORDER # (B)(4)) AND THERE WAS NO QUICK-CONNECT SYSTEM USED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25362209 ↗

Other Hamilton Medical AG products

• HAMILTON-C12 models · 2,012 reports · 2 recalls
• HAMILTON-G52 models · 1,891 reports
• HAMILTON-C22 models · 853 reports · 1 recall
• HAMILTON-MR12 models · 151 reports · 2 recalls
• Breathing circuit set, coaxial4 models · 24 reports · 2 recalls