HAMILTON-G5 Ventilator with software versions between V2 — Class I medical device recall Z-0151-2016
Terminated recall by Hamilton Medical, Inc., reported 2015-11-11, distributed nationwide. Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a
| Recall number | Z-0151-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical, Inc., Reno, NV, United States |
| Recall initiated | 2014-04-22 |
| Classified | 2015-11-04 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2017-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,128 |
| Serial numbers | 1014, 1231, 1233, 1234, 1235, 1278, 1294, 1296, 1413, 1414, 1415, 1417, 1418, 1419, 1420, 1593, 1594, 1595, 1600, 1601, 1602, 1603, 1605, 1606, 1607 and 475 more |
| Model numbers | 1590001, 159700 |
Product
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Reason for recall
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
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-0151-2016. 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.