Philips’ Perspective on Its Consent Decree with the Department of Justice
Philips confirms that its subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA.
Tag: Recalls
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Seismic Shifts in the Sleep Therapy Landscape (Editor’s Message)
Tremblors from the Philips CPAP recall continue to shift the therapy landscape in sleep medicine.
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4 High-Engagement Sleep Medicine Topics of 2023 (Editor’s Message)
Here is a recap of the topics that most engaged sleep specialists in 2023.
How Patients and Doctors Are Navigating the Fallout of the Massive Recall of Philips Breathing Machines
ProPublica journalist and filmmaker Liz Moughon on making a documentary that captures the impossible choices facing sleep apnea patients who relied on the dangerous Philips DreamStation breathing machines.
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Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls
Congressional investigators are launching an inquiry into the FDA’s oversight of medical device recalls following reports that the agency failed to issue warnings about breathing machines capable of sending hazardous particles and fumes into the lungs of patients.
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FDA: ResMed Recall for CPAP Masks With Magnets Classified as Class I
The FDA has identified ResMed’s recall of over 20 million AirFit and AirTouch CPAP masks with magnets as a Class I recall, the most serious type of recall. There have been six reported injuries.
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Claims Period Now Open for Philips CPAP Users in $479M Settlement Deal
Medical providers and patients who leased, rented, or purchased recalled Philips CPAPs, BiPAPs, or ventilators—as well as payers who reimbursed recalled devices—can now file a claim for a share in the company’s $479 million settlement deal.
Read More“With Every Breath” Captures the Human Toll of Philips’ Failure to Disclose Dangerous Defects of Its CPAP Devices
“With Every Breath,” a new documentary from ProPublica and the Pittsburgh Post-Gazette, is an intimate glimpse into what happens when patients and a doctor learn that a lifesaving device may be causing harm.
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Unmasking the Risks of Magnetic CPAP Masks
Following warnings that CPAP masks with magnetic closures may interfere with certain medical devices and implants, sleep physicians have questions. Here’s what to know.
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Millions of People Used Tainted Breathing Machines. The FDA Failed to Use Its Power to Protect Them.
The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs, according to a new report from ProPublica.
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Philips Raises Outlook Amid Ongoing CPAP Recall Challenges
Philips raised its 2023 earnings outlook following an uptick in third-quarter sales, despite ongoing challenges related to its CPAP and ventilator device recall.
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New Bill Aims to Streamline Medical Device Recall Notifications
US Senator Dick Durbin and US Representative Jan Schakowsky have introduced legislation to reform medical device recalls in an effort to improve patient safety.
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Senator Calls for DOJ Action Against Philips for Keeping CPAP Machine Complaints Secret
Sen. Richard Blumenthal is calling for “immediate, aggressive action” against Philips for keeping known defects with the company’s CPAP machines secret.
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Philips Agrees to FDA’s Call for More Testing on Recalled CPAP Devices
Philips Respironics says it plans to conduct additional testing on certain CPAP and respiratory devices involved in its June 2021 recall at the request of the FDA.
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FDA: Philips CPAP Recall Testing Inadequate to Fully Evaluate Risks
The FDA has requested Philips conduct additional testing on its recalled CPAP, BiPAP, and ventilator devices, calling testing to date inadequate to fully evaluate the risks posed to users.
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ProPublica and the Pittsburgh Post-Gazette Have Sued the FDA for Records Related to Recalled Breathing Machines
ProPublica and the Pittsburgh Post-Gazette have filed suit against the US Food and Drug Administration, accusing the agency of holding back records related to the recall of breathing machines.
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What You Need to Know About the Philips Respironics CPAP Recall
A look at answers to some of the most critical questions about the ongoing recall of millions of CPAP machines, ventilators, and other breathing devices.
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Philips Disagrees with Media Characterizations in Recall Saga
Philips is responding to recent media articles that claim the company knew about safety issues with certain CPAP machines and ventilators for years before recalling the devices in June 2021.
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