Tag: CPAP Recall
Philips now has ‘clarity’ to rebuild
January 31, 2024Liz Beaulieu, Editor
AMSTERDAM – With a consent decree nearly finalized and a more streamlined product portfolio, Philips believes its sleep and respiratory care business “bottomed out” at EUR 1 billion in revenues for 2023 and will "build back from there,” says CEO Roy Jakobs.
The company announced on Jan. 29 that it has agreed on the terms of a consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory...
Philips posts FAQ on silicone foam
December 26, 2023HME News Staff
AMSTERDAM – Philips posted a new FAQ to its website on Dec. 22 that explains the use of silicone sound abatement foam in its DreamStation 2 and other sleep and respiratory devices that were remediated as part of its June 2021 recall. “We have received a number of questions about the silicone sound abatement foam used in repaired and new replacement devices, as well as widely in the industry,” the company states. “We believe it is important that patients, care providers...
FDA issues warning for DreamStation 2
November 29, 2023HME News Staff
AMSTERDAM – The U.S. Food and Drug Administration yesterday issued a safety communication to inform users of possible thermal issues with the Philips Respironics DreamStation 2 CPAP machine and to advise them to monitor the machines for signs of overheating.
The FDA recently received medical device reports (MDRs) associated with issues like fire, smoke, burns and other signs of overheating while using the machine. The agency is in ongoing discussions with Philips about...
FDA requests more testing from Philips
October 6, 2023HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled Philips ventilators and BiPAP and CPAP devices.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA stated. “Although Philips concluded that the exposure to foam particles...
In brief: Philips refutes claims, MA premiums remain stable, NCPA supports CVS lawsuit
September 29, 2023HME News Staff
AMSTERDAM – Philips disagrees with “characterizations” in recent articles that 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 previously...
Philips reaches settlement related to CPAP recall
September 7, 2023HME News Staff
AMSTERDAM – Royal Philips has announced that the company and certain U.S. subsidiaries, including Philips Respironics, have reached an agreement to resolve all economic loss claims related to a voluntary recall of certain sleep and respiratory care devices.
The agreement, which is expected to be submitted to the U.S. District Court for the Western District of Pennsylvania later today and which is subject to that court’s approval, will provide predefined cash awards to all eligible...
In brief: Philips testing, F&P changes, Medline donation
July 26, 2023HME News Staff
AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24.
Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low...
Philips provides additional testing results on devices treated with ozone cleaning
July 25, 2023HME News Staff
AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24.
Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low...
Philips sees improvements in financial results
July 24, 2023HME News Staff
AMSTERDAM – Philips has reported 6% comparable sales growth for its Connected Care division in the second quarter, with double-digit growth in Monitoring, partly offset by a decline in Sleep & Respiratory Care.
Overall, the company reported group sales of EUR 4.5 billion and comparable sales growth of 9%.
“We are progressing to plan on our three priorities to enhance patient safety and quality, strengthen supply chain reliability, and simplify how we work, and I am pleased...
CPAP recall: When it comes to regaining trust, Philips has work to do
June 9, 2023Theresa Flaherty, Managing Editor
YARMOUTH, Maine – Two years after a recall wreaked havoc on the CPAP market, things have stabilized, but providers have mixed reviews on the way Philips handled the situation.
Philips first announced the recall of certain CPAP devices and ventilators in June 2021, sending providers on a rollercoaster of device shortages, confused patients, communication missteps and even recalls of reworked devices.
“Would I deal with Philips again?” said Tyler Riddle, president...