Philips recalls Bi-Level PAP, CPAP, mechanical ventilator devices in US
Issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices
Koninklijke Philips is recalling some Bi-Level Positive Airway Pressure (Bi-Level PAP, Continuous Positive Airway Pressure (CPAP, and mechanical ventilator devices in the US.
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. The majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family.
Despite a low complaint rate (0.03 per cent 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 PE-PUR 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 foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.
“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, Royal Philips.
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.
