HAMILTON MEDICAL, INC.

Activity by year

Devices registered here (2)

• 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
• Humidifier, Respiratory Gas, (Direct Patient Interface)
  Product code BTT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5450

Recalls & enforcement

• Class IOngoing2023-07-26
  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.
• Class IOngoing2023-06-15
  Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
• Class IIOngoing2017-06-20
  Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
• Class IITerminated2016-09-26
  Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
• Class IITerminated2016-03-09
  After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
• Class IITerminated2015-06-01
  An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation d…
• Class IITerminated2015-03-24
  Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
• Class ITerminated2014-04-22
  Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
• Class IITerminated2013-09-26
  Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
• Class ITerminated2012-12-19
  Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin t…

FDA inspections (1)

• NAI2024-07-31
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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, INC.

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)