FDA (Devices) recall action 88333
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.
Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
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 EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.
Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.
Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.
Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.