HAMILTON MEDICAL AG

Activity by year

Devices registered here (2)

• Humidifier, Respiratory Gas, (Direct Patient Interface)
  Product code BTT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5450
• Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  Product code BZE (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5270

Recalls & enforcement

• Class IOngoing2026-05-29
  Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Pr…
• Class IIOngoing2026-05-22
  Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
• Class IOngoing2025-06-26
  Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia,…
• Class IOngoing2025-06-03
  A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
• Class IOngoing2024-05-15
  Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mo…
• Class IIOngoing2023-03-14
  Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+…
• Class IIOngoing2022-09-22
  Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.
• Class IOngoing2022-06-27
  Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspira…
• Class IIICompleted2021-01-05
  When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no …
• Class ITerminated2019-03-25
  New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alt…
• Class IIOngoing2018-03-12
  After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
• Class IITerminated2018-03-09
  An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

FDA inspections (2)

• VAI2022-07-21
  Voluntary Action Indicated · Compliance: Devices
• VAI2016-02-18
  Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by Hamilton Medical AG
• Hamilton Medical AG (CH)
• Hamilton Medical AG (CH)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)