Recall Z-2795-2018 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
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.
| Date | Mar 9, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 16 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140939 | HAMILTON-T1,HAMILTON-C1 Hamilton Medical AG, Sep 2, 2015 |