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 C1 Ventilator REF 161001 1610010 Is intended to provide Recalled by Hamilton Medical, Inc. Due to Due to a software anomaly after approximately 91...

Date: June 15, 2023
Company: Hamilton Medical, Inc.
Status: Ongoing
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 C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates

Quantity: 689 systems

Why Was This Recalled?

Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.

Where Was This Sold?

U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 - Puerto Rico O.U.S.: Bahamas, Japan and Mexico

About Hamilton Medical, Inc.

Hamilton Medical, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

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