Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator… — Class II medical device recall Z-2796-2018
Terminated recall by Hamilton Medical AG, reported 2018-08-22, distributed in CA, CO, IL, LA, MN, NY, OK, VA…. An out of specification component on the control board may cause the ventilator to open the inspiratory channe
| Recall number | Z-2796-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, Switzerland |
| Recall initiated | 2018-03-09 |
| Classified | 2018-08-13 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2019-03-18 |
| Distributed | CA, CO, IL, LA, MN, NY, OK, VA, WI |
| Countries outside the US | CN, DE, ID, IL, IN, KR, PK, PL, TW |
| Quantity | 2 devices |
| Reason classes | specification failure |
| Serial numbers | 3084, 3088 |
Product
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
Reason for recall
An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.
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-2796-2018. 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.