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Tag: Philips Recall


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Philips countersues SoClean 

January 5, 2024HME News Staff

PITTSBURGH – Philips on Jan. 5 filed a counter lawsuit against SoClean and its private equity owner, DWHP, arguing they "recklessly and unlawfully” marketed their ozone cleaning devices as compatible with its CPAP and BiPAP devices.  “Contrary to SoClean’s repeated representation of compatibility, SoClean knew that its ozone cleaners had the potential to eat away at Philips Respironics’ PAPs from the inside,” the company states in the lawsuit filed...

ozone cleaning, Philips, Philips Recall, SoClean


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Senators urge GAO to review FDA oversight of recalls 

December 14, 2023HME News Staff

WASHINGTON – U.S. Senate Majority Whip Dick Durbin, D-Ill., and U.S. Sen. Richard Blumenthal, D-Conn., have sent a letter to the Government Accountability Office (GAO) calling on the agency to update its 2011 report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls” in the wake of the Philips Respironics recall.    The Senators sent the letter following the Pittsburgh Post-Gazette’s and ProPublica’s reporting on the recall of certain...

FDA oversight, Food & Drug Administration (FDA), Philips Recall, Sen. Dick Durbin, Sen. Richard Blumenthal


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Claims period opens for Philips recall 

December 12, 2023HME News Staff

AMSTERDAM – Counsel for the lead plaintiffs in the Philips recall lawsuit have announced that the claims filing period has opened for the previously announced settlement fully resolving economic loss claims. Patients and medical providers who purchased, rented or leased recalled devices, as well as payers who provided reimbursements for those payments, are eligible to participate in the settlement from Dec. 11, 2023, through Aug. 9, 2024. Under the terms of the settlement, users are eligible...

CPAP Device, Lawsuit, Philips Recall


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Roy Jakobs

Vendors

Philips takes ‘first steps’

October 27, 2023Liz Beaulieu, Editor

AMSTERDAM – Philips has re-entered the CPAP market outside of the United States, says CEO Roy Jakobs.   The company has “gradually” started serving new sleep therapy patients in several countries, now that 99% of registered devices have been remediated globally.  “This is starting across the globe,” said Jakobs during a recent conference call to discuss the company’s financial results for the third quarter of 2023. “So, Japan is an important...

CPAP, Philips, Philips Recall


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Philips refutes article claims

September 28, 2023HME News Staff

AMSTERDAM – Philips disagrees with “characterizations” made in recent articles that say the company knew for several years about problems with certain ventilators and sleep apnea devices.  ProPublica and the Pittsburgh Post-Gazette on Sept. 27 published an article saying that Philips knew about a dangerous breakdown inside its widely used ventilators and sleep apnea machines but waited years before recalling the devices in 2021.  In a statement, Philips said it had...

Philips Recall


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FDA updates Philips report count 

June 6, 2023HME News Staff

AMSTERDAM – The U.S. Food and Drug Administration received more than 6,000 medical device reports (MDRs) associated with the PE-PUR foam degradation in certain recalled Philips CPAP and BiPAP machines and ventilators from Jan. 1, 2023, through March 31, 2023, including 40 reports of death. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. A wide range of injuries have been reported in these MDRs, including...

CPAP, Food & Drug Administration (FDA), Philips Recall


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Roy Jakobs

Vendors

Philips recall update: Call-out, lawsuits, consent decree

April 28, 2023Liz Beaulieu, Editor

AMSTERDAM – Philips has clarified that, as of April 14, it has produced 2.8 million new devices and repair kits for the U.S. market, of which 2.2 million are in the hands of DME providers and patients.  The company is working to get the remaining devices and kits to providers and patients in the second quarter, said CEO Roy Jakobs during a conference call on April 24 to discuss the company’s financial results for the first quarter of 2023.  “What the call-out...

CPAP, Philips Recall, Roy Jakobs


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Philips readies to settle class action 

April 24, 2023HME News Staff

AMSTERDAM – Philips has recorded a EUR 575 million provision in the first quarter for the anticipated resolution of an economic loss class action related to its recall of certain sleep therapy and ventilator devices.  “As previously disclosed, Philips is a defendant in several class-action lawsuits and individual personal injury claims,” the company stated in a press release disclosing its financial results for the first quarter. “In the U.S., an economic loss class...

Philips, Philips Recall


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In brief: Viemed acquisition, Philips recall, Quipt public offering

April 21, 2023HME News Staff

LAFAYETTE, La., - Viemed Healthcare will acquire Tennessee based Home Medical Products, a large regional provider of respiratory focused home medical solutions.  “We are incredibly excited to complement our strong history of organic growth by combining great teams through accretive transactions” said Casey Hoyt, Viemed CEO. “The purchase of HMP will launch our acquisition growth initiatives with a stellar organization that has an extraordinary reputation with patients, payors...

1800wheelchair, Diabetes, Eversense, National Community Pharmacists Association (NCPA), National Registry of Rehabilitation Technology Suppliers (NRRTS), PAMES, Philips Recall, Quipt, Viemed Healthcare


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FDA, Philips parse device numbers

April 17, 2023HME News Staff

 WASHINGTON – The U.S. Food & Drug Administration is seeking to clarify the number of replacement and remediated devices that Philips has shipped to customers in the US.  The April 13 notice states that the FDA is clarifying that the number is considerably less than the 2,460,000 “new replacement devices and repair kits” that Philips states on its website.  “The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their...

CPAP, Philips Recall


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