FDA-Device2022-08-31Class I
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Hamilton Medical AG
Hazard
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
Sold states
US nationwide distribution including Puerto Rico.
Affected count
358
Manufactured in
Via Crusch 8, Bonaduz, Switzerland
Products
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2022Don't want to check this manually?
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