Philips reported first-quarter sales growth, plus a litigation update around its ongoing Respironics recall. Shares of PHG ticked up 14% at $21.70 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.1%. Sales for the Dutch medtech giant increased by 6% year […]
Philips Respironics
FDA questions Philips’ replacement respiratory device numbers
The FDA said today that it is clarifying claims by Philips that it has shipped 2.46 million replacement respiratory devices and repair kits in the U.S. The agency claims the number of replacement and remediated CPAPs and other respiratory devices shipped to U.S. consumers is considerably less than the 2.46 million number of “new replacement […]
Philips Respironics recalls some reworked DreamStation devices, deemed Class I by FDA
Issues for Philips (NYSE:PHG) Respironics continue as the FDA deemed a recall of reworked DreamStation devices Class I, the most serious kind. Problems have continued to mount over the past two years or so for the Dutch medtech giant. In 2021, Philips initiated a recall involving millions of CPAP and BiPAP ventilators and other respiratory devices […]
Philips recalls certain reworked Trilogy, Garbin ventilators
The FDA issued a notice labeling the recall of certain Philips (NYSE:PHG) Respironics Trilogy and Garbin ventilators as Class I, the most serious kind This recall relates to Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Philips had reworked the ventilators as it responded to its massive ongoing CPAP and BiPAP recall. Here’s […]
Philips plans to reduce global workforce by another 6,000
Philips (NYSE:PHG) reported fourth-quarter results that felt the impact of its massive Respironics recall and supply chain issues. The company also said it is cutting 6,000 jobs worldwide. The layoff comes on top of a workforce reduction of 4,000 that Philips announced in October. The Dutch medtech giant continues to work through a recall involving […]
Philips says recalled DreamStation sleep therapy device tests show ‘unlikely’ harm to health
Philips (NYSE:PHG) today issued an update following tests on health risks related to its recalled DreamStation sleep therapy devices. Amsterdam-based Philips’ testing showed that, among other things, exposure to certain emissions from the recalled devices is “unlikely to result in appreciable harm to health in patients.” The update marks the latest development in the long […]
More deaths reported in Philips respiratory devices recall
The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall. It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the […]
New Philips CEO says he is ‘deeply sorry’ over Respironics recall
Royal Philips’ new CEO Roy Jakobs has apologized for the company’s ongoing massive Respironics recalls. Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is […]
Philips Respironics CPAP, BiPAP mask recall is Class I
The FDA today issued a notice confirming that a recall of Philips (NYSE:PHG) Respironics face masks is Class I, the most serious kind. Last month, Philips provided an update on an issue with its CPAP and BiPap masks. The Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. […]
Another Philips respiratory devices recall receives a Class I label
The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification. The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk […]
Philips Respironics issues warning for magnets on CPAP, BiPAP masks
Philips (NYSE:PHG) is warning users of certain therapy masks about potential issues with implanted devices. The company’s Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps that could negatively interact with implantable, metallic medical devices. Respironics has distributed more than 17 million masks containing magnetic clips. As of […]
