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Hamilton Medical, Inc. FDA Recalls

10 recalls on file across devices, 10 of them Class I and 10 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Hamilton-C1, REF: 161001, Portable Intensive Care VentilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
Hamilton-T1, REF: 161009, Intensive Care and Transport VentilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
Hamilton-T1, REF: 161006, Intensive Care and Transport VentilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
Hamilton-MR1, REF: 161010, Intensive Care VentilatorClass IJul 26, 2023Degrading capacitors on the control board of ventilators and	Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control	Class IDevices	Jul 26, 2023
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optClass IJun 15, 2023Due to a software anomaly after approximately 91 days of cum	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the	Class IDevices	Jun 15, 2023
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrClass IJun 15, 2023Due to a software anomaly after approximately 91 days of cum	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the	Class IDevices	Jun 15, 2023
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory supClass IJun 15, 2023Due to a software anomaly after approximately 91 days of cum	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the	Class IDevices	Jun 15, 2023
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults aClass IJun 15, 2023Due to a software anomaly after approximately 91 days of cum	Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the	Class IDevices	Jun 15, 2023

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