Ventilator HAMILTON-C6 — Class I medical device recall Z-2020-2024
Ongoing recall by Hamilton Medical AG, reported 2024-06-26, distributed nationwide. Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which ma
| Recall number | Z-2020-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, N/A, Switzerland |
| Recall initiated | 2024-05-15 |
| Classified | 2024-06-18 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 68 |
| UPC / GTIN / UDI-DI | 07630002808590 |
Product
Ventilator HAMILTON-C6, PN: 160021
Reason for recall
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
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-2020-2024. 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.