Philips Korea said Monday that it has issued a recall notification for certain sleep and respiratory care devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component.
The recall, which will proceed globally, includes devices such as its bi-level positive airway pressure (Bi-Level PAP), continuous positive Airway Pressure (CPAP), and mechanical ventilator devices.
“The majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family,” the company said. “To date, Philips has produced millions of Bi-Level PAP, CPAP, and mechanical ventilator devices using the PE-PUR sound abatement foam.”
Despite a low complaint rate of 0.03 percent in 2020, Philips determined, based on testing, that there are possible risks to users related to this type of foam, it added. Such hazards include that the PE-PUR foam may degrade into particles that may enter the device’s air pathway, which may be ingested or inhaled by the user. Also, the foam may off-gas certain chemicals, according to the company.
Philips noted that the foam degradation might worsen when using unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.
“Therefore, Philips has decided to issue a recall notification to inform patients voluntarily and customers of potential impacts on patient health and clinical use related to this issue, as well as for instructions on actions required,” the company said.
Philips CEO Frans van Houten said, “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.”
In consultation with the relevant regulatory agencies and close collaboration with its customers and partners, the company is working hard towards a resolution that includes deploying the updated instructions for use and a comprehensive repair and replacement program for the affected devices, he added.
Houten stressed that patient safety is at the heart of everything they do at Philips.
Philips Korea asked customers, users, and medical staff that needs guidance and additional information related to the recall notice to contact the company’s Sleep Care Customer Center of the Sleep and Respiratory Care Division of Philips Korea or the KakaoTalk channel. Philips Korea will also be guiding follow-up measures, such as sending separate text messages to users.