Hamilton C6 REF 160021 — Class I medical device recall Z-2328-2025
Ongoing recall by Hamilton Medical AG, reported 2025-08-27, distributed nationwide. A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might
| Recall number | Z-2328-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Domat/Ems, N/A, Switzerland |
| Recall initiated | 2025-06-03 |
| Classified | 2025-08-19 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,040 systems |
| UPC / GTIN / UDI-DI | 07630002808590 |
| Model numbers | 10144626, 160021, 160021ESM |
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.
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 of the device enter ambient state, resulting in an interruption of ventilation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2328-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.