Class I — 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 I |
| Status | Ongoing |
| Reason | 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 of the device enter ambient state, resulting in an interruption of ventilation. |
| Product | 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 optionally infants and neonates. |
| Quantity | 1040 systems |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-06-03 |
| Classified | 2025-08-19 |
| Recall number | Z-2328-2025 |
| 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 I recall — Hamilton Medical AG (Z-2328-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97079/
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