Z-2795-2018 Class II Terminated
FDA device recall Z-2795-2018 was initiated by Hamilton Medical AG on Mar 9, 2018 and is designated Class II. 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… The recall status is terminated (terminated Mar 18, 2019). Affected quantity: 16 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- Mar 9, 2018
- Termination Date
- Mar 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 devices
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.
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.
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.
Code Information
Serial Number: 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, 12432
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2795-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026