HAMILTON-C6 Intensive Care Ventilator — Class I medical device recall Z-1525-2022
Ongoing recall by Hamilton Medical AG, reported 2022-08-31, distributed nationwide. Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may
| Recall number | Z-1525-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Bonaduz, Switzerland |
| Recall initiated | 2022-06-27 |
| Classified | 2022-08-19 |
| Reported by FDA | 2022-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 358 |
| UPC / GTIN / UDI-DI | 07630002808590 |
| Serial numbers | 14784, 4833, 5663, 5679, 5681, 5939, 6075, 6093, 6149, 6157, 6159, 6212, 6219, 6231, 6274, 6276, 6280, 6309, 6320, 6327, 6349, 6350, 6416, 6464, 6480 and 333 more |
| Model numbers | 160021 |
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Reason for recall
Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed
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-1525-2022. 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.