Recall Z-1525-2022— Hamilton Medical AG
Class I · Ongoing
Class I FDA medical device recall by Hamilton Medical AG, initiated 2022-06-27. It names one FDA 510(k) clearance: K201658. Product: HAMILTON-C6 Intensive Care Ventilator, REF: 160021. 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.
- Recalling firm
- Hamilton Medical AG
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-06-27
- Firm location
- Bonaduz, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.