The move will help minimise potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
Health technology company Royal Philips has voluntarily recalled certain sleep and respiratory care devices to minimise potential health risks.
Specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices have been recalled to mitigate identified potential health risks associated with the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
According to the company, the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family. The latest move follows the company update in April this year.
Philips has manufactured millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam, to date.
The risks associated with recalled devices consist of the PE-PUR foam may degrade into particles that are expected to enter the device’s air pathway and be ingested or inhaled by the user. The foam is expected to off-gas certain chemicals.
The foam degradation may be intensified by the use of unapproved cleaning methods such as ozone, as well as high heat and high humidity environments may also result in foam degradation.
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 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.”