Philips issues recall

AMSTERDAM – Royal Philips has announced, in consultation with regulatory agencies, a voluntary recall notification on certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices. 

The majority of affected devices within the advised five-year service life are in the first-generation DreamStation product family, the company says. 

“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,” said Frans van Houten, CEO of Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard toward 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.” 

Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and by high heat and high humidity environments. 

Philips says it will replace the current sound abatement foam with a new material and has already begun preparations, including obtaining the relevant regulatory clearances. The first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. 

Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issues and to support the program, the company is increasing the production of those devices that are available in the U.S. and selected countries in Europe. 

The adjustments to and acceleration of the repair and replacement program, as well as intensified communication with customers and patients, has led to an increase of EUR 250 million in the expected costs of the corrective actions on the installed base. That’s on top of the provision of EUR 250 million that Philips recorded in the first quarter of 2021. 

For patients using affected Bi-Level PAP and CPAP devices, the recall advises they discontinue use of their device and work with their physician or DME provider to determine most appropriate options for continued treatment. To continue use of their device due to lack of alternatives, patients should consult with their physician to determine if the benefit of continuing therapy with their device outweighs the risks identified. 

For patients using affected mechanical ventilator devices, the recall advises they not stop or alter their prescribed therapy until they have talked to their physician. Philips recognizes that options for therapy may not exist or may be severely limited for patients who require a vent for life-sustaining therapy, or in cases where the therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these vent devices may outweigh the risks identified in the recall notification.