Testing in accordance with ISO 18562 and ISO 10993 standards conducted by five certified, independent testing laboratories in the US and Europe This update is intended to provide healthcare providers, patients, and other stakeholders with updated information on the testing results to date. Philips will continue to provide regular updates as new […]
Tag: philips respironics
Philips Provides Update on Filed PAP/Vent Medical Device Reports
In June 2021, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and mechanical ventilator devices. At the time the […]
FDA Proposes Order for Philips to Provide CPAP Refunds
The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices […]
FDA Orders Philips Respironics to Notify Patients Regarding Recall of CPAP Devices, Vents
On March 10th, the U.S. Food and Drug Administration issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the […]
Philips Recall Update: February 3, 2022
The following email was sent to users on February 3, 2022. We’re writing to you with two important updates about your recalled Philips device.* As always, thank you for your continued patience as we work hard to ensure as many patients as possible can continue safely with their therapy. Our […]
FDA Update on Philips CPAP Recall
The U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. “Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices […]
Philips Respironics Returns to Advertising with Remote Mask Fitting
Philips Data-Driven Mask Selector Delivers Unique Patient and Business Benefits
Royal Philips has announced the launch of the Philips Respironics Mask Selector, the first and only clinically validated, 3D facial scanning solution that helps providers to fit 9 out of 10 patients with the right mask from the start [1]. The proprietary Mask Selector algorithm offers a novel solution in the […]
Philips Increases Hospital Ventilator Production, Introduces New E30 Emergency-Use Ventilator
Philips engages manufacturing partners Flex Ltd. (NASDAQ: FLEX) and Jabil (NYSE: JBL), as well as other partners, to further expand its hospital ventilator assembly lines and strengthen its supply chain Company introduces the Philips Respironics E30 ventilator, a versatile and easy-to-use ventilator to treat patients with respiratory insufficiency, designed […]
How PCP-Ordered Home RTs Slashed Readmissions and ER Visits
In a field plagued by COPD readmission rates, registered respiratory therapist (RRT) Kimberly Palczynski had a hunch that working more closely with primary care physicians might help stem the tide. But she never could have expected just how big of an impact an RT-driven, patient home care program in conjunction […]












