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Hamilton Medical Recalls
20 recalls on record · February 6, 2013 to September 27, 2023 · Medical Devices
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Hazard: 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.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Hazard: 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.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Hazard: 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.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Hazard: 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.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Hazard: 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.
September 27, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Hazard: 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.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and opt
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
August 2, 2023Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a
Hazard: Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
January 24, 2018Medical DevicesFDA
Hamilton Medical, Inc. recalls Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure
Hazard: Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
December 7, 2016Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator suppor
Hazard: Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
May 18, 2016Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology:
Hazard: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
November 11, 2015Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is d
Hazard: 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).
August 5, 2015Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700..
Hazard: 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.
July 8, 2015Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for
Hazard: 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 delivered.
July 8, 2015Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory fo
Hazard: 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 delivered.
July 8, 2015Medical DevicesFDA
Hamilton Medical, Inc. recalls Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for
Hazard: 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 delivered.
November 13, 2013Medical DevicesFDA
Hamilton Medical, Inc. recalls HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed
Hazard: Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
February 6, 2013Medical DevicesFDA
Hamilton Medical Inc recalls HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide p
Hazard: 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 than originally expected.