Class II — Hamilton Medical AG
| Recalling firm | Hamilton Medical AG |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | 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. |
| Quantity | 2 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. |
| Initiated | 2018-03-09 |
| Classified | 2018-08-13 |
| Terminated | 2019-03-18 |
| Recall number | Z-2796-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hamilton Medical AG (Z-2796-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80467/
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