Recall Z-1525-2022 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
| Date | Jun 27, 2022 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | On 6/27/22 Field Safety Notices were emailed to health care facilities, distributors, and service engineers who were informed to take the following actions: 1) In case of a loose status indicator board observed by the user, the front housing containing the status indicator board shall be replaced. This replacement prevents the water ingress that may lead to ambient state. 2) Check your affected ventilator and inform the distributor immediately if you detect the loosening of the status indicator board. 3) Your local distributor or service engineer will contact you shortly. 4) Loose status ind |
| Quantity | 358 |
| Distribution | US nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201658 | Hamilton-C6 Hamilton Medical AG, Dec 11, 2020 |