Portable ventilator, electric/47083: Trilogy Evo, O2, International – Model IN2100X15B
Product name
Portable ventilator, electric/47083: Trilogy Evo, O2, International – Model IN2100X15B
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension under paragraph 41GA(1)(b)
Grounds for regulatory action
Under paragraph 41GA(1)(b); it is likely there are grounds for cancellation of these specific models of medical devices under paragraph 41GN(1)(b) and 41GN(1)(f) on the basis that the sponsor failed to comply with a condition to which the inclusion of the kind of device in the ARTG was subject under paragraph 41FN(3)(a) and certification made by the sponsor under section 41FD is incorrect or no longer correct.
This applies to the specified models tabled below, not the entire ARTG entry. The suspension applies for the period from 25 July 2023 to 31 October 2023.
ARTG ID
ARTG Name
Model
Description
332200
‘Portable ventilator, electric’
IN2100X15B
Trilogy Evo, O2, International
336800
‘Portable ventilator, electric’
IN2200X15B
Trilogy EV300, INTL