Class I — Hamilton Medical, Inc.
| Recalling firm | HAMILTON MEDICAL, INC. |
|---|---|
| Registered facility | HAMILTON MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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). |
| 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 |
| Quantity | 1128 |
| Distribution | Nationwide Distribution |
| Initiated | 2014-04-22 |
| Classified | 2015-11-04 |
| Terminated | 2017-08-24 |
| Recall number | Z-0151-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Hamilton Medical, Inc. (Z-0151-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72319/
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