FDA (Devices) recall action 98540
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips Respironics is recalling the Trilogy Evo O2 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Philips Respironics is recalling the Trilogy Evo ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Philips Respironics is recalling the Trilogy Evo Universal ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.
Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.