Tag: DreamStation
In brief: AAH’s call to action, DreamStation’s new designation, CMS’s new ABN
March 20, 2026HME News Staff
WASHINGTON – AAHomecare is urging providers to build support for the DIABETES Act (S. 4037), which, among other things, would delay Medicare competitive bidding for continuous glucose monitors (CGMs) and insulin pumps for five years.
The bill, which was introduced March 12 by Sens. Jeanne Shaheen, D-N.H., and Susan Collins, R-Maine, would also expand Medicare coverage of diabetes self-management training sessions.
AAHomecare says stakeholders can build important early support for this...
Philips DreamStation receives medically necessary designation for certain patients
March 19, 2026HME News Staff
ANDOVER, Mass. – Philips has announced that DreamStation BiPAP AVAPS devices have been designated as medical necessary for lower-weight patients with breathing impairment. The devices, which include S, T, S/T, and PC modes with AVAPS, are available for sale in the United States for new setups for patients with obstructive sleep apnea (OSA) and respiratory impairment, who are both >7 years of age and weighing 40-66 pounds. “Patient safety is at the...
Philips removes certain DreamStation devices
September 15, 2025HME News Staff
WASHINGTON – Philips Respironics has removed certain DreamStation devices due to programming errors that can result in failed therapy modes, according to the U.S. Food and Drug Administration.
The affected devices are:
DreamStation Auto CPAP UDSX500S11F 00606959423314
DreamStation Auto BiPAP UDSX700S11F 00606959423338
DreamStation Auto CPAP UFRX500S14 00606959455045
Reason for recall
Philips Respironics is recalling certain DreamStation...
Providers say Lincare allegations are ‘infuriating’
December 6, 2024Theresa Flaherty, Managing Editor
YARMOUTH, Maine – Providers still bruised by the Philips recall say allegations that Lincare received 20,000 replacement CPAP devices and then turned around and used them for new patients instead of existing patients adds insult to injury.
The allegations were published by ProPublica, a nonprofit investigative journalism organization, in a Nov. 13 article.
“During a time when the rest of us were drowning and Philips couldn’t give us any machines, Lincare capitalized...
Philips recalls certain reworked devices
April 7, 2023HME News Staff
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,”...
Philips completes testing for first-gen DreamStation devices
December 23, 2022Liz Beaulieu, Editor
Company has spent 18 months testing exposure to particulate matter and VOC emissions from degraded foam in its first-generation DreamStation CPAP devices
It has shared test results and assessments with the U.S. Food and Drug Administration but does not have a timeline for when it will hear back
Right now, there are no changes to guidance for health care providers and patients
AMSTERDAM – Philips officials say a now completed set of test results and assessments of recalled...
Philips: ‘We have better understanding of the potential health risks’
December 21, 2022HME News Staff
AMSTERDAM – Exposure to particulate matter emissions from degraded foam in first-generation DreamStation devices is unlikely to result in harm to patients and exposure to volatile organic compounds is not anticipated to result in long-term health consequences for patients, according to the latest test results and assessments from Philips.
Additionally, presence of visible foam degradation in inspected returned devices was found to be low: Of 36,341 returned devices from the U.S. and...
Philips Respironics provides testing update
December 27, 2021HME News Staff
AMSTERDAM – Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.
The announcement comes after an assessment by an outside medical panel and Philips and is intended to give healthcare providers the most recent data. Overall guidance for physicians and patients in the recall notification remains unchanged.
At...
Philips updates providers on FDA report
November 30, 2021HME News Staff
AMSTERDAM, the Netherlands – Philips does not anticipate a delay to its recall or replacement program as a result of a recent report from the U.S. Food and Drug Administration, the company told its provider customers in a Nov. 23 letter.
The FDA recently published the results of its inspection of Philips’ manufacturing facility, noting the silicone-based foam used in a singular, similar CPAP/BiPAP device marketed outside of the U.S. failed one safety test for the release of volatile...
Philips begins remediation
September 1, 2021HME News Staff
AMSTERDAM, the Netherlands – Royal Philips has received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month.
The company has also started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices, which aren’t affected by the recall.
“We fully recognize...