Search results
In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only).
- Patients
Patients - Medical Device Recall Information - Philips...
- Business customers
Business customers - Medical Device Recall Information -...
- Clinicians
Clinicians - Medical Device Recall Information - Philips...
- News and Updates
News and Updates - Medical Device Recall Information -...
- Contact and support
Contact and support options for patients impacted by the...
- Ozone Cleaner Information
“Follow the CPAP manufacturer’s instructions and recommended...
- Starts Repair and Replacement
Philips has received authorization from the US Food and Drug...
- Patients
In June 2021, Philips initiated a voluntary recall notification / field safety notice for certain CPAP and BiPAP sleep therapy devices and mechanical ventilators to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices.
6 paź 2023 · Together with five independent, certified testing laboratories, Philips Respironics conducted extensive testing. Based on the results to date, Philips Respironics concluded that use of its sleep therapy devices are not expected to result in appreciable harm to health in patients.
5 paź 2023 · In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive...
29 sty 2024 · In 2021, Philips Respironics determined from user reports and initial testing that there were possible risks to users related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and ventilator devices. Following the issuance of the recall
The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.
14 cze 2021 · Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies. Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices.
