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.
This recall has been terminated (originally issued March 9, 2018).
- Recall Initiated
- March 9, 2018
- Terminated
- March 18, 2019
- Recall Number
- Z-2796-2018
- Quantity
- 2 devices
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Serial Number: 3084, 3088
Root Cause
Nonconforming Material/Component
Action Taken
Hamilton Medical notified customers on about 03/09/2018 via letter. Instructions included that a Hamilton Medical Field Service Representative will be in contact with each customer to schedule the correction. Questions or concerns can be directed to Hamilton Technical Support at 1-800-426-6331, option #2.