Tag: Philips Recall
Philips consent decree outlined
April 8, 2024HME News Staff
PITTSBURGH – The provisions of a consent decree between Philips Respironics and the U.S. Department of Justice were outlined in an April 4 filing in federal court, including selecting and retaining an independent expert to conduct inspections at certain facilities for several years.
The expert will conduct audit inspections every six months for a period of two years and then once every year thereafter for a total of five years at four facilities in Pennsylvania and one facility in...
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...
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...
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...
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...
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...
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...
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...
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...
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...