If you’re a patient in the United States and you’ve registered your device for remediation, this site will allow you to check the status of your replacement device order. If you are a non-U.S. patient, please contact your homecare provider for updates.On this site, you can: Check ...
On June 14, 2021, Philips announced a voluntary recall notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines*. 1. Sound abatement foam may degrade into particles which may enter the device’s air pathway...
The recall involves specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices to address potential health risks related to polyester-based polyurethane sound abatement foam that is in the machines, Philips said in a...
Years of Philips CPAP Recalls and Concerns Philips’ troubled history of mechanical ventilator recalls began in June 2021, when 15 million Philips Respironics machines were recalled. The initial recall showed foam contained within the devices could break down over time and be inhaled. Millions of peo...
illions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure machines, known as CPAP or BiPAP depending on their design, are sophisticated medical devices that have bee...
On June 30, 2021, the U.S. Food and Drug Administration issued aSafety Communicationabout Philips’ voluntary recall of some of its BiPAP, CPAP and ventilator devices. Philips is the largest producer of CPAPs in the world, as many as four million machines could be affected. People who can...
The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices. That includes 561 reports of death, the agencysaidWednesday. ...
Initially recalled two-and-a-half years ago, the Food and Drug Administration has since received 105,000 complaints — including 385 reported deaths — tied to leaking foam in the continuous positive airway pressure (CPAP) machines. Philips attempted to fix some of the more than 5 million recal...
Richard Callendar has used a Philips Respironics CPAP machine for years after a bilateral lung transplant and a kidney transplant. "It's about time. This has been going on, there's been complaints about the machine as far back as 2010," Callendar said. ...
Initially recalled two-and-a-half years ago, the Food and Drug Administration has since received 105,000 complaints — including 385 reported deaths — tied to leaking foam in the continuous positive airway pressure (CPAP) machines. Philips attempted to fix some of the more than 5 million recal...