Tag: Philips Recall

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...

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...

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...

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...

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...

 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...

ELYRIA, Ohio – Invacare has filed a Form NT 10-K notifying the U.S. Securities and Exchange Commission that it is unable to file its annual report for the period ending Dec. 31, 2022, within the prescribed time period due to its Chapter 11 bankruptcy filing.  “Due to the considerable time and resources the company’s management is devoting to the Chapter 11 cases, and the need to prepare and review the disclosures required in the Form 10-K as a result of the Chapter 11 cases,...

WASHINGTON – The U.S. Food & Drug Administration on April 7 announced Philips has recalled certain reworked DreamStation CPAP, BiPAP devices for the risk they may deliver inaccurate or insufficient therapy.  The company is recalling 1,088 devices that were distributed between Dec. 1, 2021, and Oct. 31, 2022.  “Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming,”...

Increase in setups, along with national insurance contracts, will pave way for the company to hit 8% to 10% organic growth in 2023  CINCINNATI – January marked the first month since June 2021 that Quipt Home Medical did not have allocation limits on a connected CPAP device and, exiting the first quarter of its fiscal year, the company expects to be back at pre-pandemic levels for patient setups, says CEO Greg Crawford.  “This real-time development is a powerful tailwind...

AMSTERDAM – Philips says it filed about 78,800 complaints with the U.S. Food and Drug Administration between April 2022 and December 2022 that were allegedly associated with possible foam degradation in recalled CPAP, BiPAP and ventilator devices.  The company says most of these medical device reports (93%) were due to alleged technical malfunctions that do not involve serious injury.  “It is important to note that the submission of an MDR itself is not evidence...