Tag: Philips

AMSTERDAM – Philips has issued a recall for its V60 and V60 Plus ventilators equipped with high-flow therapy software versions 3.00 and 3.10 due to the risk of patients receiving reduced oxygen. The number of such devices recalled in the U.S.: 16,535. V60 and V60 Plus ventilators equipped with high-flow therapy are used to provide patients with breathing assistance at high concentrations of oxygen at a higher flow than typical oxygen therapy. These devices include a design safety mechanism...

AMSTERDAM – Philips reported a 16% decline in sales for its Connected Care business, which includes Sleep and Respiratory Care, for the second quarter of 2021 compared to the same period last year, in the wake of a massive recall of certain CPAP devices and ventilators.  Mid-single-digit growth in Hospital Patient Monitoring was more than offset by a double-digit decline in Sleep & Respiratory Care, the company says.  “We have mobilized the necessary resources across the...

AMSTERDAM – The U.S. Food and Drug Administration has classified the voluntary recall of certain Philips CPAP devices and ventilators as Class I.   The FDA defines Class I as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”  The agency posted recalls for the various affected devices, along with their classification, to its database on July 13 and July...

AMSTERDAM – Royal Philips has announced, in consultation with regulatory agencies, a voluntary recall notification on certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  The majority of affected devices within the advised five-year service life are in the first-generation DreamStation product family, the company says.  “We...

BALA CYNWYD, Pa. – Connect America.com, an independent provider of medical alert systems in North America, has signed a definitive agreement to acquire the Aging and Caregiving business of Royal Philips. The ACG business offers the Lifeline Personal Emergency Response System (PERS) and senior living solutions with 24/7 access to trained care specialists, and digital solutions that help caregivers stay connected and coordinate the needs of loved ones. “Connect America and Philips...

CAMBRIDGE, Mass. – There’s only a “small risk” that the sound abatement foam in the first-generation DreamStation is being compromised by outside factors, including ozone cleaners, but Philips has chosen to be proactive and fix or replace these CPAP devices in the U.S., says CEO Frans van Houten. The occurrence rate of deterioration of the foam is about 0.03%, based on internal user reports and testing, the company says. “The use of ozone is typically a U.S....

CAMBRIDGE, Mass. – Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of the company’s sleep and respiratory care devices.  “The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone, and certain environmental conditions involving high humidity and temperature,” the company stated...

AMSTERDAM, the Netherlands – Automatic telemonitoring algorithms like the Philips Adherence Profiler are relevant tools for early prediction of CPAP therapy adherence, according to a recently published study in the journal Sleep and Breathing. They also may make it possible to focus therapeutic follow-up efforts on patients who are at risk of non-adherence, the study says. The study, which involved 457 patients in France, tested the predictive value at day 14 of the Philips Adherence Profiler...

AMSTERDAM, the Netherlands - The COVID-19 pandemic has created unique challenges for the COPD community, but it has also increased awareness of the condition and pushed patients to pursue alternative care options, according to the first ever World COPD Day survey by Royal Philips. “Despite impacting millions of people around the world, COPD isn't talked about as often as other chronic conditions like heart disease,” said Huiling Zhang, head of medical office for connected care at Philips....

AMSTERDAM - Royal Philips announced Monday that it has received notice from the U.S. Department of Health and Human Services that its contract to deliver 43,000 bundled EV300 ventilator configurations through December 2020 has been partially terminated. Philips delivered 12,300 bundled vent configurations to the Strategic National Stockpile by the end of August, but it will no longer supply the remaining 30,700 Philips EV300 vents. “To date, we have delivered on our commitments to HHS,”...