Hamilton Medical Ag

Reports per year

Source: FDA adverse event reports by year received, 2008–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Ventilator, Continuous, Facility UseCBK16,171
• Cuff, Tracheal Tube, InflatableBSK208
• Set, Tubing And Support, Ventilator (W Harness)BZO89
• Humidifier, Respiratory Gas, (Direct Patient Interface)BTT28
• Tubing, Pressure And AccessoriesBYX7
• Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE5
• Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI5
• Compressor, Air, PortableBTI2
• Attachment, Breathing, Positive End Expiratory PressureBYE1
• Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR1

Recent recalls

• 2026-07-01Open, ClassifiedProcess design

  IntelliCuff, Portable automatic cuff pressure controller REF: 951001

  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.

• 2026-06-30Open, ClassifiedComponent design/selection

  Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

  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: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement

• 2025-08-19Open, ClassifiedEquipment maintenance

  Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.

  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.

• 2025-07-30Open, ClassifiedProcess control

  Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

  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, respiratory acidosis, and if unrecognized organ dysfunction.

• 2024-06-18Open, ClassifiedPackaging change control

  Ventilator HAMILTON-C6, PN: 160021

  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 mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

• 2023-04-25Open, ClassifiedSoftware design

  HAMILTON-C6, REF: 160021

  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+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

• 2022-11-18Open, ClassifiedUnder Investigation by firm

  Hamilton-C6

  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.

• 2019-07-11TerminatedSoftware design

  HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

  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, alternative ventilation must be provided immediately.

• Open, ClassifiedOther

  Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

  After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.

• Open, ClassifiedOther

  Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.

  After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.