Tag: Recall

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material.  “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine...

AMSTERDAM – Philips has established a “recovery trajectory” for its sleep and respiratory care business, but discussions with the U.S. Department of Justice on a proposed consent decree to resolve identified issues could impact the company’s plans. The company’s trajectory includes an estimated EUR 600 million in sales of Respironics sleep systems by 2025, up from an expected EUR 200 million in 2022 and more in line with the EUR 700 million in 2019, pre-recall.  “This...

WASHINGTON – AAHomecare has developed a letter that providers can send to payers explaining the CPAP device shortage and asking them to temporarily relax compliance requirements. In the wake of supply chain challenges related to semiconductor chips, manufacturers have released products that don’t have wireless cell modem data tracking technology for recording patient compliance data. The letter asks payers to remove, for a limited period of time, any policy requiring patient compliance...

AMSTERDAM, the Netherlands – Philips’ plan to remediate an additional 300,000 devices will push the completion date of its recall into 2023, but the company recorded additional provisions in the first quarter to speed up the process as much as it can.  Philips now expects to complete more than 90% of production and shipments to customers by the end of 2022, said Frans van Houten, CEO, during an April 25 conference call to discuss the company’s financial results for...

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...

YARMOUTH, Maine – A majority of HME providers have expanded the number of brands they carry in the past year due to ongoing supply chain issues and price increases, according to a recent HME Newspoll.  Nearly 76% of respondents say they now carry more brands than they used to.  “While efficiency is better with fewer brands, I’ve found it more important, especially in the past year, to ensure having multiple backup brands ready at a moment’s notice,” wrote...

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...

SAN DIEGO - ResMed, in consultation with the Australian Government Department of Health Therapeutic Goods Administration, has initiated a product correction recall in that country for its Astral 100 and Astral 150 ventilators due to an internal battery issue. Starting in September, local service providers will be contacting patients to schedule replacement of affected batteries, either at the next normal routine maintenance service or at a separate appointment. All ventilators should have their internal...