FDA (Devices) recall action 98537
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.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
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 using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.
Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.