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September 1, 2021. Philips has received authorization from the US Food and Drug Administration (FDA) to begin the repair and/or replacement process for affected first-generation DreamStation devices in the US1. The company is also initiating repair and/or replacement programs in other countries and expects to have these underway in the majority ...
An update on our progress. Globally, we have remediated 99% of actionable* sleep therapy device registrations to date. As the remediation of the ventilator devices continues, Philips Respironics will be communicating with Durable Medical Equipment providers (DMEs) directly throughout the process. If you are a patient or caregiver with an ...
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Aug 27, 2021 · 877-907-7508. August 27, 2021 - Updates to selected Questions and Answers.
Important information for clinicians. We are fully committed to partnering with you to support your patients. Together with five independent, certified testing laboratories and third-party experts, Philips Respironics has conducted extensive testing since June 2021. Based on the results to date, Philips Respironics and the third-party experts ...
Apr 10, 2024 · April 10, 2024. Completing the Philips Respironics medical device recall remains our highest priority. With the remediation of the sleep therapy devices almost complete and remediation of the ventilators ongoing, it is important that patients, Durable Medical Equipment providers (DMEs) and clinicians are informed on the latest updates.
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement ...
