Recall Notification

On June 14, 2021 Philips Respironics issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), 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.

Potential Foam Degradation

Philips Respironics reports that it has received a low complaint rate (0.03% in 2020). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. 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.

For full details, to include registering your device, click here.

For the full release from the FDA, click here Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

Patient can voluntarily report observe or suspected adverse events for human medical products to FDA.  Voluntary reporting can help the FDA identify unknown risk for approved medical products. If you would like to complete a voluntary report, click here. MedWatch Online Voluntary Reporting Form (fda.gov)

On June 14, 2021 Philips Respironics issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), 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.

Potential Foam Degradation

Philips Respironics reports that it has received a low complaint rate (0.03% in 2020). However, Philips determined based on testing that there are possible risks to users related to the type of foam used in these devices. The risks include that the foam may degrade into particles, which may enter the device’s air pathway and be ingested or inhaled by the user. Potential risks include headache and respiratory problems. The foam also may off-gas certain chemicals. 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.

For full details, to include registering your device, click here.

For the full release from the FDA, click here Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

Patient can voluntarily report observe or suspected adverse events for human medical products to FDA.  Voluntary reporting can help the FDA identify unknown risk for approved medical products. If you would like to complete a voluntary report, click here. MedWatch Online Voluntary Reporting Form (fda.gov)