FDA Device recall Z-1874-2019
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation o…
- FDA Device
- Class I
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class I recall of HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation o… by Hamilton Medical Ag, citing 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 opene….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1874-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-25 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hamilton Medical Ag |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial numbers 16192 and lower |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1874-2019%22
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