Hamilton Medical AG: Medical Device Recall in 2018 - (Recall #: Z-2795-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.

Product Classification:

Class II

Date Initiated: March 9, 2018

Date Posted: August 22, 2018

Recall Number: Z-2795-2018

Event ID: 80467

Reason for Recall:

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

Status: Terminated

Product Quantity: 16 devices

Code Information:

Serial Number: 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, 12432

Distribution Pattern:

US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

Voluntary or Mandated:

Voluntary: Firm initiated