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Tag: Recall


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Philips recalls certain V60 vents

August 5, 2021HME News Staff

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...

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Vendors

Philips sees sales fall for Sleep & Respiratory Care

July 26, 2021HME News Staff

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...

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FDA classifies Philips recall as ‘serious’

July 26, 2021HME News Staff

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...

CPAP, FDA Classification, Philips, Recall, ventilator


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Providers rethink product choices

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Providers rethink product choices

July 22, 2021Liz Beaulieu, Editor

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...

Home Medical Equipment, Recall


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Frans van Houten

Vendors

Philips issues recall

June 14, 2021HME News Staff

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...

CPAP Devices, DreamStation, Ozone, Philips, Recall, Sound Abatement Foam


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Also Noted

ResMed recalls vents in Australia

September 1, 2016HME News Staff

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...

Astral 100, Astral 150, Recall, ResMed


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Philips Respironics recalls 600 vents

February 20, 2014HME News Staff

MURRYSVILLE, Pa. - Philips Respironics initiated a worldwide recall of 600 Trilogy Ventilators, models 100, 200 and 202, according to a Feb. 19 release. The voluntary recall is to address a potential defect in part of the power management board, which could cause the ventilator to fail without an alarm indicating a problem, the release says. The recall affects devices shipped between Dec. 30, 2013, and Jan. 30, 2014. Philips Respironics asks customers to stop using the devices and return them to...

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Tandem expands voluntary recall of insulin cartridges

January 21, 2014HME News Staff

SAN DIEGO - Tandem Diabetes Care is expanding the voluntary recall of certain lots of insulin cartridges used with the t:slim insulin pump, the company announced Jan. 20. The cartridges may leak, which could result in the pump delivering too much or too little insulin, according to the statement. “We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent...

Insulin cartridges, Kim Blickenstaff, Recall, Tandem Diabetes Care


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Nipro initiates voluntary recall

January 3, 2014HME News Staff

FORT LAUDERDALE, Fla. - Nipro Diagnostics has initiated a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack blood glucose meters. The company has determined that certain meters distributed in the United States have an incorrect factory-set unit of measure that displays the result in mmol/L rather than mg/dL. If a user didn't notice the incorrect unit of measure, it is possible that the result could be read as lower than expected. The recall affects 501 TRUEbalance...

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Vendors

Invacare initiates recall

October 18, 2013Liz Beaulieu, Editor

ELYRIA, Ohio - Invacare has a big ask for HME providers.On Oct. 2, Invacare sent providers a packet of information on a widespread recall of certain joysticks and driver controls on power wheelchairs manufactured between Oct. 1, 2006, and March 21, 2013. The ask: Using the provided serial numbers, identify customers who received wheelchairs with these products, remove them and swap them out for new ones.“We know a lot is being asked of our provider customers,” said Lara Mahoney, director...

Invacare, Lara Mahoney, mk6i driver controls, Recall, spj+ joysticks


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