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).
Are you or your patient waiting for a replacement device? We may be trying to reach you for more information or to take additional action.
Philips Respironics completed the analyses for System One and DreamStation Go sleep therapy devices indicating that the volatile organic compounds (VOCs) and the particulate matter (PM) emissions related to foam degradation are within the appliable safety limits. Additional visual assessments have been performed and confirm the low prevalence of significant foam degradation.
August 7, 2023
Click here to learn moreJune 29, 2023
Click here to learn moreJune 12, 2023
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Click here to learn moreDecember 14, 2022
Click here to learn moreAugust 11, 2022
Click here to learn moreJune 28, 2022
Click here to learn moreJune 1, 2022
Click here to learn moreSeptember 3, 2021
Click here to learn moreSeptember 1, 2021
Click here to learn more * As of August 31, 2023 ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Repair kits are utilized in the rework process to create a recertified unit. To learn more, click here.
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