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# Philips Respironics Reports More Problems with Ventilators
- URL: https://www.fdaweb.com/philips-respironics-reports-more-problems-with-ventilators/
- Published: 2022-11-18T12:00:00.000Z
- Updated: 2026-09-14T18:07:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153230

FDA says it has asked for additional information from Philips Respironics after it reported two new potential issues with an ongoing recall of its Trilogy ventilators that have been “reworked” as a part of a 6/2021 recall. The information request is intended to help FDA better understand the cause of the issues and to provide informed recommendations to patients, caregivers, and health care professionals, an agency [update notice](https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due?ref=fdaweb.com) says.

The first issue, FDA says, involves the new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam. The foam may “potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure,” it says.

The other issue is related to trace amounts of particulate matter that have been found in the air pathway of some reworked ventilators. “Particulate samples were sent to a third-party lab for evaluation. Preliminary results show PE-PUR and environmental debris in some samples, and in others only environmental debris,” it says.

Phillips has been under the microscope as it struggles to resolve issues surrounding its troubled ventilators, continuous positive airway pressure, and bilevel positive airway pressure machines. Earlier this year, it said it was undergoing discussions ([see story](https://www.fdaweb.com/philips-discussing-consent-decree-over-respironics-recalls/)) with the Department of Justice (DoJ) on behalf of FDA about the proposed terms of a consent decree. In April, the company said it received a DoJ subpoena asking for information on the events that led to recent recalls of the devices ([see earlier story](https://www.fdaweb.com/justice-department-probe-on-philips-respironics-recall/)).