HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402… — Class II medical device recall Z-0170-2014
Terminated recall by Hamilton Medical, Inc., reported 2013-11-13, distributed nationwide. Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were excee
| Recall number | Z-0170-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical, Inc., Reno, NV, United States |
| Recall initiated | 2013-09-26 |
| Classified | 2013-11-06 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 316 devices |
Product
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
Reason for recall
Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
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-0170-2014. 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.