Drug recall
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure…
FDA recall event 80467 · Class II · Hamilton Medical AG
Key facts
| Event ID | 80467 |
|---|---|
| Recall numbers | Z-2795-2018, Z-2796-2018 |
| Recalling firm | Hamilton Medical AG |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 9, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Mar 18, 2019 |
| City | Bonaduz |
| Country | Switzerland |
| FEI number | 3001421318 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: