Company: Hamilton Medical
Date of Enforcement Report: 7/12/2019
Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
Recall Number: Z-1874-2019
New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted. When the ventilator enters the ambient state, alternative ventilation must be provided immediately.
Hamilton Medical on 3/25/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Nationwide and International