Class I — Serious Health Hazard

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...

Date: December 19, 2012
Company: Hamilton Medical Inc
Status: Terminated
Source: FDA (Device)

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.

Affected (51 states)Not affected

About Hamilton Medical Inc

Hamilton Medical Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report