Consent Decree Finalized Against Philips Respironics
Details of the finalized consent decree against Philips Respironics, sparked by the potential health risks of its CPAP devices, are revealed.
Tag: Philips Respironics
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Philips Agrees to FDA Consent Decree Over CPAP Recall
Until the requirements of the consent decree are met, Philips Respironics will not sell new CPAP, BiPAP, or other respiratory care devices in the US.
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Philips Gradually Re-Enters CPAP Markets
Customers are welcoming Philips Respironics CPAP devices back in markets around the globe, according to Philips CEO Roy Jakobs.
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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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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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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We Spent a Year Investigating the Philips CPAP Recall. Here’s How We Did It.
To understand the breakdowns that led to one of the most tumultuous medical device recalls in generations, ProPublica and the Pittsburgh Post-Gazette spent a year probing what happened inside Philips Respironics after the company first learned that contaminants were turning up in breathing machines designed to save lives.
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Exor Buys Minority Stake in Philips
Exor NV, a Netherlands-based diversified holding company, has bought a 15% stake in Royal Philips, with an option to increase it to 20%.
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Philips: Sleep Therapy Devices Pass Ozone Cleaning Analysis
Philips Respironics provided the latest results and conclusions on the comprehensive test and research program to assess potential health risks related to the polyester-based polyurethane sound abatement foam in specific sleep therapy and ventilator devices under the voluntary June 2021 recall.
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Philips: ‘99%’ of Replacement Sleep Therapy Devices Produced
Philips Respironics provided an update on the field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
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40 More Deaths Reported in Philips Recall
The FDA updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.
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Philips Completes Risk Assessments for Recalled CPAPs and BiPAPs
Royal Philips’ CEO says the third-party risk assessments for the sleep therapy devices under the June 2021 recall are “positive and reassuring.”
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Philips CEO: Resolving Recall Remains ‘Our Highest Priority’
Philips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
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FDA: Philips’ Website Overstates Number of Replacement Devices Shipped
The FDA says Philips’ published number of repairs and replacements includes manufactured repair kits that Philips shipped internally to its facilities.
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