This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Names: HAMILTON-C6 ventilator
Unique Device Identifier (UDI)/Model:
- UDI: 76300028PN160021ZW
- Model: 160021
Lot/Serial Numbers: 13636–13950 and 13966–14753

What to Do

Identify affected devices. Coordinate with the local Hamilton partner to replace the ESM circuit board with a new board installed by a trained service technician.

On June 3, 2025, Hamilton Medical AG emailed all affected customers an Urgent Medical Device Correction letter recommending the following actions:

Review HAMILTON-C6 devices and identify units within the affected serial number ranges.
Notify healthcare professional teams about this safety notice.
Coordinate with the local Hamilton partner to replace the ESM circuit board with a new board installed by a trained service technician.
Return confirmation of repair to the local partner within 45 days of receiving the firm’s notice.

Reason for Recall

Hamilton Medical AG is correcting HAMILTON-C6 ventilators because certain ESM circuit boards may have mechanical pre-damage from printed circuit board (PCB) separation at the supplier. The defect can cause a short circuit that prevents startup or causes the ventilator to enter an ambient state during use, interrupting ventilation.

The use of affected product may cause serious adverse health consequences, including trouble breathing (respiratory failure), low blood oxygen (hypoxemia), damage to the brain or other organs, and death.

There have been no reported injuries or deaths related to this issue.

Device Use

The HAMILTON-C6 is a facility-use ventilator intended to provide positive pressure ventilatory support for adults, pediatrics, and optionally infants and neonates. It can be used in intensive care units, intermediate care units, emergency wards, long-term acute care hospitals, recovery rooms, and during intra-hospital transport.

Contact Information

Customers in the U.S. with questions about this recall should contact Hamilton Medical AG (Vigilance Team) at fieldactions.med.global@hamiltonmedical.com.

Additional FDA Resources (listed in order of most to least recent):

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.