Philips Respironics, Inc.: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Hazard

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Details from the source

Reason for recall: In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. Distribution: Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, I Quantity: 113,717 units Lot/code info: All Model No.; All UDI; All Serial No.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.