Company: Hamilton Medical
Date of Enforcement Report: 7/12/2019
Class I
PRODUCT
Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001)
Recall Number: Z-1874-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Hamilton Medical on 3/25/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4338 units
DISTRIBUTION
US Nationwide and International