Jun 16, 2021 – Royal Philips has provided an update on the recall notification for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
Philips has issued a voluntarily recall notification to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.
The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.
Philips determined based on testing that there are possible risks to users related to PE-PUR sound abatement foam they are made with.
The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.
The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments may also contribute to foam degradation.
Philips 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.
Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue, the company says.