HAMILTON-G5Recalls & reported problems across all models

We found 2 models of HAMILTON-G5 by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 1,891 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2021 and Sep 30, 2026 — classified as 21 deaths, 32 injuries, 1,838 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (327 reports).

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

Most reported HAMILTON-G5 problems

HAMILTON-G5 models

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

• HAMILTON-G5 159001

  Oximeter
  18 deaths1,440 reports
• HAMILTON-G5 159002

  Oximeter
  3 deaths451 reports

Recent HAMILTON-G5 adverse event reports

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

• MalfunctionSep 30, 2026No Flow

  Hamilton Medical AG received the following event description: TF 5509 and TF 9907 occured during ventilation. Also there is "Power fail" recorded in the logs. Medical intervention was reported, ventilator was replaced. It was reported that the event did not lead to any serious injury or adverse health effects for any patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945196 ↗
• MalfunctionSep 30, 2026Infusion or Flow Problem

  Hamilton Medical AG received the following event description: "TF 5509. Inspiration valve fault. Problem occured during ventilation, resulting in ambient mode." Medical intervention was reported, ventilator was replaced. It was reported that the event did not lead to any serious injury or adverse health effects for any patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942911 ↗
• MalfunctionSep 30, 2026Intermittent Continuity

  Hamilton Medical AG received the following event description: "TF 9905, 9906, 9907 PERSISTING EVEN WHEN IN TEST MODE."No patient involvement. The event did not lead to any serios injury or adverse health effects to any patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942698 ↗
• MalfunctionJun 30, 2026Improper Flow or Infusion

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "DURING INSPECTION, WE FOUND THAT A SELF-TEST FAILED ALARM WAS DISPLAYED ON THE MACHINE. WE SUSPECTED AN ISSUE WITH THE SERVO MODULE. TO CONFIRM THE FAULT, WE CROSS-CHECKED BY INSTALLING A NEW SERVO MODULE, AND THE MACHINE OPERATED NORMALLY. THEREFORE, THE FAULTY SERVO MODULE WAS REPLACED WITH A NEW ONE. ALL TESTS AND CALIBRATIONS WERE COMPLETED SUCCESSFULLY AFTER THE REPLACEMENT. THE MACHINE WAS HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION." NO PATIENT INVOLVEMENT WAS REPORTED. NO HARM, SERIOUS INJURY OR ADVERSE HEALTH CONSEQUENCES TO ANY PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664229 ↗
• DeathJun 25, 2026Insufficient Device Problem Information

  SEE A FACEBOOK VIDEO OF A HAMILTON G5 THAT IS SEVERLY BURNED, SEE ALSO A VENTILAIR MAYBE EVEN AN H900, NOT SURE. SEVERELY BURNED. VIDEO STATES ALLEGED DEATH: HTTPS://WWW.FACEBOOK.COM/THENURSEERICA/VIDEOS/4488099788184556/ LINK TO VIDEO.

  Patient problems: Insufficient Information

  MAUDE report 25629411 ↗
• InjuryJun 24, 2026Mechanical Jam

  COMPLAINT REPORTED TO HMI CLINICAL APPLICATION SPECIALIST: DURING INTERHOSPITAL TRANSPORT OF A PATIENT THE USER REPORTED A "NO OXYGEN" FAILURE WHEN CONNECTED TO O2 TANK. THE PATIENT BEGAN TO DESATURATE SO THE USER SWITCHED THE O2 TANK. ONCE IN THE ROOM THE USER REMOVED THE VENTILATOR AND SWITCHED TO ANOTHER HAMILTON-G5. REPORTED VENTILATOR SETTINGS WERE: "100% 02, PEEP +16, VT 430, RR 28, 5L FLOW TRIGGER." (DESCRIPTION OF EVENTS PROVIDED BY RT MANAGER AT FACILITY, NOT PRESENT DURING THE EVENT. DIRECT REPORT FROM USER NOT AVAILABLE AT THIS TIME.)

  Patient problems: Low Oxygen Saturation

  MAUDE report 25615934 ↗
• MalfunctionJun 5, 2026Gas/Air Leak

  IT WAS REPORTED TO HAMILTON MEDICAL AG THE TECHNICAL EVENT ERROR 8912 - PUMP RUNS AND HAS PRESSURE BUT NEVER SHUTS OFF AND DOES NOT REACH TARGET PRESSURE OF 25, PUMP IS LEAKING. AT THE TIME OF THE EVENT, THE PATIENT WAS CONNECTED TO THE VENTILATOR. NO INTERVENTION WAS DEEMED NECESSARY, AND NO INJURY OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406572 ↗
• MalfunctionMay 27, 2026Infusion or Flow Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING VENTILATION, THE DEVICE WAS AUTO-CYCLING AND ALARMED WITH DISCONNECTION ON VENTILATOR SIDE. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298989 ↗
• MalfunctionMay 19, 2026Failure to Calibrate

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "TF 5507 HAPPENED AFTER CALIBRATION ATTEMPTED TO CALIBRATE THE PRESSURE AT 0 AND FULL SCALE. TRIED CALIBRATING THE DP MIXER VALVE" IT WAS REPORTED NO HEALTH CONSEQUENCES OR IMPACT TO ANY PATIENT. NO INTERVENTION NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215985 ↗
• MalfunctionApr 23, 2026Gas Output Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "TF: 9907 & 5509 ALARM, AND THE UNIT CANNOT USE." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964644 ↗
• MalfunctionApr 23, 2026Failure to Calibrate

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "INSPIRATORY VALVE MALFUNCTION. FAILED DURING STARTUP. TF5509 AND TF9907. OCCURS EVERY TIME VENT IS POWERED ON" NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964394 ↗
• MalfunctionApr 7, 2026Pressure Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG: "REPORTED TF 9612 WHEN CO2 CABLE IS CONNECTED. NO PATIENT HARM, DISCOVERED DURING PM. INITIATING WPO FOR REPLACEMENT MOTHERBOARD." NO PATIENT WAS INVOLVED. EVENT OCCURRED DURING THE PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799188 ↗
• MalfunctionApr 6, 2026False Positive Result

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT THE HAMILTON-G5 VENTILATOR DISPLAYED THE TECHNICAL FAULT: "TF 5507". 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 24789293 ↗
• MalfunctionApr 2, 2026Failure to Recalibrate; Failure to Calibrate

  IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: ¿TF 5510 TF 5511 AFTER CALIBRATING FLOW SENSOR SEVERAL TIMES. MANUAL SAYS TO REPLACE SENSOR BOARD¿ NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764463 ↗
• MalfunctionMar 30, 2026Deflation Problem

  IT WAS REPORTED TO HAMILTON MEDICAL AG: ¿FAULT 8912¿ 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 24729664 ↗

Other Hamilton Medical AG products

• HAMILTON-C12 models · 2,012 reports · 2 recalls
• HAMILTON-T15 models · 1,185 reports · 3 recalls
• HAMILTON-C22 models · 853 reports · 1 recall
• HAMILTON-MR12 models · 151 reports · 2 recalls
• Breathing circuit set, coaxial4 models · 24 reports · 2 recalls