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# Philips Respironics Software Correction Class 1: FDA
- URL: https://www.fdaweb.com/philips-respironics-software-correction-class-1-fda/
- Published: 2024-10-02T12:00:00.000Z
- Updated: 2026-09-14T14:43:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157905

FDA says the Philips Respironics 7/16 mandatory software correction and updated use instructions for its Trilogy Evo, EV300, EvoO2, and Evo Universal ventilators is a Class 1 recall. An agency 10/1 [notice](https://www.fda.gov/medical-devices/medical-device-recalls/ventilator-software-correction-philips-respironics-issues-mandatory-software-correction-and-updates?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the corrections were made to resolve several previously reported and also new safety issues that may affect the device’s ability to support patient breathing.

The use of affected products may cause serious adverse health consequences, FDA says, including hypoventilation, hypoxia, and death. There have been one reported death and nine reported injuries, the notice says.