Sleep Physician Sentenced to Prison for Altering Recalled CPAPs
He was sentenced to over a year in prison and ordered to pay restitution for manually removing foam from recalled devices and billing them to Medicaid as new.
Tag: Recalls
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FDA Pilot Aims to Improve Timeliness of High-Risk Medical Device Recall Alerts
The pilot aims to minimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.
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Philips to Pay $1.1 Billion in US Settlement Over Sleep Apnea Devices
The company anticipates the settlement will resolve all personal injury and medical monitoring claims related to its June 2021 recall.
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.
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The Changing Landscape of CPAP Cleaners Post Philips Recall
Amid scrutiny over CPAP cleaning devices, including legal disputes and FDA warnings, the industry sees a movement back to manual cleaning methods.
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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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Eco Terra Mattresses Recalled Due to Fire Hazard
Sleep Technologies has issued a recall for its Eco Terra Hybrid Latex Mattresses over concerns of a potential fire hazard.
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FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.
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FDA: 111 More Deaths Reported in Philips Recall
The FDA provided an update on medical device reports, including reports of new deaths, that the agency received relating to Philips’ recall from July 1 to Sept 30, 2023.
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Home Design Recalls of Over 500,000 Beds Due to Fall and Injury Risks
Home Design has received 128 reports of the beds breaking, sagging, or collapsing, including 36 injuries.
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Jerry McGinnis, Respironics Founder, Dies at 89
Gerald “Jerry” E. McGinnis, founder of Respironics, died on Jan 25 at age 89.
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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.
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Philips Axes Sleep and Respiratory Lines
Philips Respironics released a lengthy list of discontinued products and their sales and shipment discontinuation dates. Orders unable to be shipped will be canceled.
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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.
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Philips Recalled Breathing Machines in 2021. Chemicals of “Concern” Found in Replacement Machines Raised New Alarm.
Amid a massive recall in 2021, the medical device maker Philips raced to overcome troubling questions about its replacement machines as customers waited for help.
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