Philips Respironics Archives - Medical Design Sourcing

Philips discontinues certain CPAP product lines after recall saga, stock sinks on Q4 results

The now-discontinued DreamStation Go portable CPAP system. [Image from Philips]Philips (NYSE: PHG) + has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio.

The Dutch medtech giant began dealing with troubles within its Respironics business in mid-2021. Philips recalled more than 5 million devices since then due to the dangerous degradation of sound abatement foam. The FDA logged more than 100,000 reports of problems related to the recall. At least 385 related to deaths.

While the company continues to work through its remediation process, more light has been shed on how the recall unfolded as it did. ProPublica and the Pittsburgh Post-Gazette first reported that Philips withheld its CPAP issues from the FDA for years. The reporting later revealed CEO Roy Jakobs’ apparent knowledge of the ongoing issues and alleged approval of the sale of defective d…

Report: Concerning chemicals found in replacement Philips CPAPs

The Philips DreamStation 2 continuous positive airway pressure (CPAP) device [Photo courtesy of Philips]Replacement machines issued by Philips (NYSE: PHG) + amid its respiratory device recall may have more issues, according to ProPublica and the Pittsburgh Post-Gazette.

Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at least 385 linked to deaths.

While the company continues to work through its remediation process, more light has been shed on how the recall unfolded as it did. ProPublica and the Pittsburgh Post-Gazette first reported that Philips withheld its CPAP issues from the FDA for years. The reporting later revealed CEO Roy Jakobs’ apparent knowledge of the ongoing issues and alleged approval of the sale of defective devices.

The latest repo…

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

U.S. senators call for review of FDA following Philips recall fallout

[Image by f11photo via stock.adobe.com]Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Philips (NYSE: PHG) + Respironics recall.

Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls.”

Durbin and Blumenthal’s scrutiny of FDA oversight comes in the wake of several developments in Philips’ respiratory device recall.

Since mid-2021, more than 5 million Philips Respironics devices have been recalled due to dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.

While the company continues to work though its remediation process, mor…

Philips CEO Roy Jakobs reportedly approved continued sale of defective sleep respiratory devices

Philips CEO Roy Jakobs [Image courtesy of Royal Philips]A new report from ProPublica and the Pittsburgh Post-Gazette claims to shed more light on the alleged role of Philips (NYSE: PHG) + CEO Roy Jakobs in the ongoing Respironics recall.

Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. This timeline lays out the events of the ongoing saga.

ProPublica and the Post-Gazette previously released a scathing investigation outlining the alleged withholding of information around the issues with the devices even as they became more alarming.

The latest from the news outlets says the company decided to stop shipping defective devices in April 2021 after tests showed exposure to potentially dangerous particles. Philips alerted the FDA to the po…

FDA wants more testing in Philips recall

The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG) + .

The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.)

Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga.

FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming.

“Th…

The Philips CPAP recall settlement could be just be the start

Philips (NYSE: PHG) + is set to pay at least $479 million to settle claims related to its ongoing Respironics recall.

It could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.)

Subject to approval in the U.S. District Court in Western Pennsylvania, the deal only covers economic losses incurred by the users of millions of Philips CPAPs and other respiratory devices recalled over sound abatement foam that could potentially degrade and get into airways. The $479 million amount is the minimum that Philips has agreed to pay.

“This uncapped settlement is one of the largest consumer class action settlements ever negotiated, and I expect it will be worth substantially more than the prefunded amounts as more users of recalled Philips devices enroll in the settlement and seek out compe…

Philips reaches settlement in class-action lawsuit over sleep apnea machine recall

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it reached a class-action settlement on economic loss claims related to its ongoing Respironics recall.

The agreement resolves all economic loss claims in the U.S. multidistrict litigation (MDL) related to the voluntary recall. Philips expects to submit the settlement to the U.S. District Court for the Western District of Pennsylvania later today, Sept. 7. Subject to court approval, the settlement includes no admission of liability, wrongdoing or fault by any of the Philips parties.

A press release from the co-lead plaintiffs counsel — Sandra L. Duggan of Levin Sedran & Berman LLP; Kelly K. Iverson of Lynch Carpenter LLP; Christopher A. Seeger of Seeger Weiss LLP; and Steven A. Schwartz of Chimicles Schwartz Kriner & Donaldson-Smith LLP — stated that Phil…

Philips Respironics has a Class I level ventilators recall

The FDA has posted information on its website about another serious recall involving Philips Respironics products.

This time, the Class I recall covers 73,000 Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators in the U.S. It’s the Philips subsidiary’s 11th serious recall listed on the FDA’s Medical Device Recalls webpage since 2021 — when a global recall involving millions of CPAPs and other respiratory products with potentially degraded sound abatement foam sidelined the Dutch medtech giant from the market.

According to the FDA, Philips initiated the recall of Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators on March 22 after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure or air volume/flow.…

Philips: Study shows recalled CPAPs unlikely to cause appreciable harm

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]Philips (NYSE:PHG) today shared results from a test and research program for the ongoing recall within its Respironics subsidiary.

The Amsterdam-based medtech giant says third-party test results determined that issues around its respiratory devices are unlikely to cause appreciable harm to health. These now-completed risk assessments fall in line with results shared by Philips in late 2022. At that point, testing covered just over two-thirds of registered devices in the recall. To date, risk assessments are complete for approximately 95% of registered devices.

In a news release, CEO Roy Jakobs said Philips’ “first priority” remains the health and well-being of patients. He explained that the test and research program offers clarity on safety and helps provide replacement devices to patients.

“The third-party risk assessmen…

Philips recalls certain reworked Trilogy, Garbin ventilators

The Trilogy 200 ventilator [Image courtesy of Philips]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 the Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Its impact does not extend to the massive, ongoing CPAP and BiPAP recall.

Here’s a timeline of how the recall unfolded.

Philips also recalled the Trilogy and Garbin ventilators affected by this issue in June 2021, when its Respironics recall began. This recall covers certain reworked ventilators with adhesive issues. The reworked or replaced CPAP and BiPAP machines do not use adhesive to hold the silicone foam in the devices.

In November 2022, Philips warned that reworked Philips Respironics Trilogy ventilators have two new potential issues. The company said the Trilogy 100/200 ventilators with potential additional problems make up roughly 3% o…

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 millions of CPAPs and other respiratory devices. (Here is a full timeline of the recall.)

Half the cuts will take place this year. The remainder will be done by 2025. The layoffs represent about 13% of Philips’ global workforce.

“Right now, it is very important to lead with realism. I am also a great believer in knowing where I want to go and having a clear plan to get there, a plan that people can understand and have confidence in,” CEO Roy Jakobs said during the company’s earning’s call.

Despite its struggles, Jakobs said he embraced the challenges and that he he was exci…