Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON Recalled by Hamilton Medical Inc Due to Analysis of a customer complaint has shown that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hamilton Medical Inc directly.
Affected Products
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Quantity: 97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hamilton Medical Inc
Hamilton Medical Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report