HAMILTON-C6 — Class II medical device recall Z-1429-2023
Ongoing recall by Hamilton Medical AG, reported 2023-05-03, distributed nationwide. Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode wit
| Recall number | Z-1429-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, N/A, Switzerland |
| Recall initiated | 2023-03-14 |
| Classified | 2023-04-25 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 103 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07630002808590 |
| Model numbers | 160021 |
Product
HAMILTON-C6, REF: 160021
Reason for recall
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
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-1429-2023. 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.