HAMILTON-C2Recalls & reported problems across all models
Hamilton Medical AG · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one HAMILTON-C2 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 853
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 1
We found 2 models of HAMILTON-C2 by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 853 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2022 and Dec 8, 2025 — classified as 15 injuries, 838 malfunctions.
The most frequently reported specific device problem is “Defective Component” (192 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Reports received per month, all models
HAMILTON-C2 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.
- 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-2141-2023 · Root cause: Software design · Recall details · FDA record ↗
Most reported HAMILTON-C2 problems
Device problems
- Defective Component192
- Gas/Air Leak110
- Display or Visual Feedback Problem82
- Decrease in Pressure62
- Failure to Calibrate53
- Computer Software Problem52
- Failure to Power Up50
- Failure of Device to Self-Test37
Patient problems
- No Clinical Signs, Symptoms or Conditions829
- Delirium15
- Low Oxygen Saturation13
- Ventilator Dependent10
- Insufficient Information7
- Hemorrhage/Blood Loss/Bleeding2
- Cyanosis1
- Decreased Respiratory Rate1
HAMILTON-C2 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HAMILTON-C2 160001Ventilator, Continuous, Facility Use1 recall807 reports
- HAMILTON-C2 160002Ventilator, Continuous, Facility Use46 reports
Recent HAMILTON-C2 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Disconnection; Disconnection
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): DURING AN EMERGENCY RESCUE, THE HAMILTON-C2 VENTILATOR FAILED AND COULD NOT BE USED AS INTENDED. MEDICAL STAFF IMMEDIATELY SWITCHED TO A MANUAL RESUSCITATION BAG TO PROVIDE VENTILATION, WHICH CAUSED A BRIEF DELAY IN INITIATING RESPIRATORY SUPPORT. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741937 ↗MalfunctionSep 18, 2025Insufficient Cooling; Insufficient Cooling
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): THE DEVICE ALARMED WITH ¿FAN FAILURE¿ DURING AND AFTER STARTUP. THE ISSUE WAS IDENTIFIED DURING A NON-CLINICAL PROCEDURE USING A TEST LUNG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23081856 ↗MalfunctionJul 22, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION BASED ON THE CURRENT INFORMATION OF THE COMPLAINT (SUMMARY OF THE REPORTER): "VENTILATOR SHOWING BLOWER SERVICE REQUIRED AND SELF TEST FAILED." ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563284 ↗MalfunctionMay 23, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY OF THE CUSTOMER/REPORTER): WHITE & BLUE SCREEN DURING VENTILATION WITH ERROR CODE. NO PATIENT WAS HARMED, THE BEHAVIOR CAN BE REPLICATED. NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22076758 ↗MalfunctionMar 19, 2025Circuit Failure; Circuit Failure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "WHILE DEVICE WAS ON STANDBY WE GET AUDIBLE/VISIBLE ALARM AND TF 485001, TF 446029, TF 446022, TF 446030 AT RANDOM TIMES. STARTUP PROCEDURE IS OK AND DEVICE PASSES SERVICE TESTS BUT WHILE DOING THE TESTS I DID GET SAME TF CODES ONCE WHILE DOING O2 CALIBRATION AND ONCE WHEN DEVICE WAS IN SERVICE MODE "MAIN SCREEN". LOGS." HEALTH IMPACT: NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642231 ↗MalfunctionMar 4, 2025Decrease in Pressure; Decrease in Pressure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "VENTILATOR SHOWS TECHNICAL FAULT TECHNICAL FAULT (TF) 431002 (BLOWER DISCONNECTED) ON STARTUP." NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21513227 ↗MalfunctionFeb 26, 2025Decrease in Pressure; Decrease in Pressure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "TECHNICAL EVENT (TE (B)(4): BLOWER CONTROLLER SPEED LOW) DURING VENTILATION AND LATER SELF TEST FAILED AT STARTUP." HEALTH IMPACT: ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21466652 ↗MalfunctionFeb 25, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "VENTILATOR SHOWS TECHNICAL FAULT TECHNICAL FAULT (TF) 431002 (BLOWER DISCONNECT) ON STARTUP." HEALTH IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WERE REPORTED. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21456753 ↗MalfunctionFeb 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): DISPLAY FLICKERING DURING START UP. HEALTH IMPACT: NONE. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS REPORTED. PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21456306 ↗MalfunctionFeb 18, 2025Gas/Air Leak; Gas/Air Leak
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): THE COMPLAINT HAS BEEN RECEIVED AS " AMBIENT TEST FAILED, AFTER THE AMBIENT VALVE EXCHANGE, THE DEVICE WORKS WITHOUT ANY FAILURE." THE AMBIENT VALVE TEST FAILED IN SERVICE SOFTWARE. HEALTH IMPACT: NONE, NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395097 ↗MalfunctionFeb 13, 2025Decrease in Pressure; Decrease in Pressure
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "- TE 231009 (ALARM BLOWER SPEED LOW) - BLOWER FLOW TEST FAILED - BLOWER PRESSURE TEST FAILED - BLOWER MODULE ASSEMBLY REPLACED." NO HEALTH IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21372453 ↗MalfunctionFeb 10, 2025Power Problem; Power Problem
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): LOSS OF EXTERNAL POWER, AC POWER NOT INDICATING, POWER SUPPLY BOARD REPLACED. HEALTH IMPACT: NONE, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342884 ↗MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER/REPORTER): "RELEASE VALVE DEFECTIVE/TIGHTNESS TEST FAILS." HEALTH IMPACT: NONE, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342665 ↗MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING: (1) COMPLAINT DESCRIPTION (QUATATION FROM THE CUSTOMER/REPORTER): "AFTER STARTUP DEVICE GIVES 231007 (O2 CONTROLLER FLOW HIGH) AND 231008 (O2 VALVE LEAK) TECHNICAL EVENT. CAN HEAR THAT HPO O2 IS LEAKING SOMEWHERE. FROM SERVICE MENU - SENSOR DATA - FLOW SENSOR QO2 IS SHOWING ~17L/MIN EVEN WHEN FLOW IS SET TO 0." (2) HEALTH IMPACT: NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341559 ↗MalfunctionFeb 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (QUOTATION OF THE CUSTOMER): "DISPLAY BLANK AND SOMETIMES FLICKERING DISPLAY." NO PATIENT INVOLVEMENT DURING MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321529 ↗
Other Hamilton Medical AG products
All Hamilton Medical AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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