HAMILTON-G5 — Class I medical device recall Z-1874-2019
Terminated recall by Hamilton Medical AG, reported 2019-07-17, distributed nationwide. New software version for affected ventilators reduces the probability of the ventilator entering an ambient st
| Recall number | Z-1874-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, Switzerland |
| Recall initiated | 2019-03-25 |
| Classified | 2019-07-11 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2024-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 4,338 units |
| Reason classes | software |
| Serial numbers | 16192 |
Product
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
Reason for recall
New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.
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-1874-2019. 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.