The Magazine for Sleep Professionals
Friday, April 10, 2026
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The […]
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 […]
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 […]
With a grant from the National Institute of Science, Eclipse™ will launch late in the third quarter of 2022. Eclipse uses MagSeal™ technology to ensure a rapid on/rapid off interface. Like the DreamPort also by Bleep, Eclipse™ optimizes PAP users comfort by removing all of the headgear and straps and […]
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 […]
Fisher & Paykel Healthcare has announced the United States launch of F&P Evora™ Full, a compact full-face mask for obstructive sleep apnea (OSA) treatment. The mask has received FDA 510(k) clearance, paving the way for its sale into the United States following its launch in Australia, New Zealand, Europe and […]
Fisher & Paykel Healthcare Corporation Limited provided revenue guidance for the financial year ending 31 March 2022. At current exchange rates, the company expects full year operating revenue for the 2022 financial year to be in the range of $1.675 billion to $1.70 billion. Managing Director and Chief Executive Officer […]
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 […]
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 […]
SoClean Inc. has filed a federal lawsuit in the United States District Court for the District of Massachusetts against Philips. According to the complaint, Philips has misled the public and engaged in acts of deliberate misdirection, placing blame on SoClean to divert attention away from obvious design flaws, including a poor choice […]
