On June 14th, Philips (Respironics) issued a recall notification for specific Philips bi-level positive airway pressure (BPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices. The recall is in response to potential health risks related to the sound abatement foam component in these devices, which helps the machine run quietly. The majority of the affected devices are in the first-generation DreamStation product family, but Philips reports that the recently launched DreamStation 2 is not affected by the issue.
Although the reported complaint rate has been low at 0.03% in 2020, testing done by Philips indicate that there are possible risks to users related to the type of polyester-based polyurethane (PE-PUR) foam used in these devices.
NOTE: Philips indicates that this foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone. High heat and high humidity environments also may contribute to foam degradation.
Philips has advised patients using affected BPAP and CPAP devices to discontinue use.
Philips plans to address all affected devices as quickly as possible. Philips is creating a registration process that will allow patients to look up their device serial number and begin a claim if the unit is affected. Within the next week or so, patients will be able to look up their device serial number and begin a claim if the unit is affected at the following website.
Patients can call Philips at 877-907-7508 for additional support.