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Hamilton Medical AG recalls HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Recalled August 31, 2022 · FDA recall Z-1525-2022 · 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 · FDA Class I
Units
358
Sold at
US nationwide distribution including Puerto Rico.
Description
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
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Manufacturer(s)
Hamilton Medical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →