Hamilton Medical issued an Urgent Medical Device Correction letter for its Hamilton-C6 ventilators due to an issue that may prevent startup or cause the ventilator to enter an ambient state during use, interrupting ventilation, according to an FDA alert.

According to the FDA, Hamilton Medical AG emailed all affected customers the Urgent Medical Device Correction letter due the possibility of certain C6 ESM circuit boards having mechanical pre-damage from printed circuit board separation at the supplier. The FDA reports that this defect can cause a short circuit that prevents startup or causes the ventilator to enter an ambient state during use, interrupting ventilation.

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, according to the FDA.

The FDA has identified this recall as the most serious type and warns that use of affected product may cause serious adverse health consequences, including respiratory failure, hypoxemia, damage to the brain or other organs, and death.

There have been no reported injuries or deaths related to this issue, the FDA says.

Affected Product

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

FDA Recommendations

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.