Hamilton Medical Ventilator Recall Deemed Class I

2023-10-19

FDA recently announced that Hamilton Medical is recalling its Hamilton C1/T1/MR-1 ventilators. The recall is identified as Class I.

The company originally sent an Urgent Medical Device Correction letter to customers July 26, writing that degrading capacitators on the control board and spare parts may leak electrolyte fluid onto the control board, potentially causing a short circuit. If a short circuit were to occur, the ventilator could switch to “Ambient State” or a “realtime clock failure”.

If the realtime clock failure appears on the screen, the user will be notified to set a date and time, but the error will not have severe effects on the operation of the device. The Ambient State failure, on the other hand, requires immediate action, according to Hamilton. Ambient State may require clinicians to provide manual or alternative air supply to a patient. Ventilators with this failure could result in serious injury or death for patients if not noticed and provided immediate intervention.

Of note, Hamilton said there have been zero reported incidents, injuries, or deaths related to the recall. Currently, 1,468 devices have been recalled in the United States with distribution dates of July 28, 2020, to August 8, 2020.

Affected model numbers include:

Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part

The recall is considered a correction and not a product removal because the device can be returned to use after passing service software tests. The company requests that customers affected by the recall provide alternative ventilation immediately if the Ambient State screen appears and switch off the power to the ventilator to exit the failure screen.

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