On March 25, United States District Court Judge Rebecca L. Pennell sentenced Dr. Eric Edward Haeger, age 57, of Brewster, Washington, to one year and a day in federal prison followed by a one-year term of supervised release after Haeger pleaded guilty to adulterating and misbranding medical devices with the […]
Tag: philips recall
FDA Warns of Overheating Philips’ DreamStation 2 CPAP Machines
As part of the U.S. Food and Drug Administration’s continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treatment of obstructive sleep apnea. The […]
Recall Update: Philips Tests Foam From Returned PAP Machines
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 […]
Innovative CPAP Training Device to Debut at SLEEP 2022
SleepRes, LLC introduces the V̇-Com™ at SLEEP2022/APSS this week, a revolutionary device to make CPAP more comfortable and increase adherence. The V̇-Com™, which softens peak inspiratory flow, makes starting CPAP easier and faster. “This may be the most important comfort factor in the PAP circuit since we developed BiPAP over […]
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 […]
FMCSA’s MRB Advises Current CPAP Trucking Guidelines Following Phillips Recall
Due to potential health risks, Philips Respironics voluntarily recalled certain continuous positive airway pressure (CPAP) machines over the summer. , the polyester-based polyurethane (PE-PUR) sound abatement foam runs the risk of breaking down and potentially entering the device’s air pathway. Under these circumstances, it is said that black debris from […]












