Philips Issues Recall for Some of its Ventilators and Sleep Apnea Devices

The impetus behind the recall stems from the fact the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways.

Omar Ford

June 14, 2021

1 Min Read
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Claudio Divizia - stock.adobe.com

Some of Philips’s ventilators and sleep apnea machines are facing a recall. The Amsterdam, Netherlands-based company issued a recall for its Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family. 

The impetus behind the recall stems from the fact the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways. Gases released by the degrading foam may also be toxic or carry cancer risks.

Philips’s recall would impact between three million and four million devices, according to a report from Reuters.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” Frans van Houten, CEO of Royal Philips said in a release. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”

Philips said it is providing the relevant regulatory agencies with required information related to the launch and implementation of the projected correction. The company will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. Philips aims to address all affected devices in scope of this correction as expeditiously as possible.

 

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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