Hamilton Medical Ventilator Recall Deemed Class I

The recall is considered a correction and not a product removal because the device can be returned to use after passing service software tests.

Katie Hobbins, Managing Editor

October 19, 2023

2 Min Read
Hamilton C1/T1/MR-1 ventilators
Image courtesy of Hamilton Medical

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.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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