Z-2796-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- March 9, 2018
- Termination Date
- March 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
Product Description
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or 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: 3084, 3088