Drug recall
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator…
FDA recall event 97079 · Class I · Hamilton Medical AG
Key facts
| Event ID | 97079 |
|---|---|
| Recall numbers | Z-2328-2025 |
| Recalling firm | Hamilton Medical AG |
| Product type | Devices |
| Products | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use… |
| Initiation date | Jun 3, 2025 |
| Report date | Aug 27, 2025 |
| City | Domat/Ems |
| Country | Switzerland |
| FEI number | 3014766741 |
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: