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Tag: Recall


Also Noted

FDA announces Ventec vent recall 

March 11, 2024HME News Staff

WASHINGTON – The U.S. Food and Drug Administration has announced a recall of the Ventec Life Systems VOCSN patient breathing package (pediatric, active, oxygen, blue) for a manufacturing issue with its bonded spiral wrap. The recall, a Class I or most serious type of recall, is a correction, not a product removal. The issue: The spiral wrap detaching before or during ventilation, with the potential of compromising the structural integrity and functionality or of causing blockage, stoppage or...

Recall, Ventec, ventilators, VOCSN


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Also Noted

Philips sends more MDRs to FDA 

February 5, 2024HME News Staff

WASHINGTON – Philips has submitted more than 7,000 medical device reports, including 111 reports of death, for July 1, 2023, to Sept. 30, 2023, that are associated with the breakdown or suspected breakdown of the foam used in the ventilators and BiPAP and CPAP devices included in its large recall, according to the U.S. Food and Drug Administration. Since April 2021, the company has submitted more than 116,000 MDRs, including 561 reports of death, reportedly associated with the breakdown or...

Medical Device Reports (MDRs), Philips, Recall


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Providers

Providers feel squeezed in wake of Philips exit

February 2, 2024Theresa Flaherty, Managing Editor

YARMOUTH, Maine – Even after enduring the roller-coaster of doing business with Philips Respironics the past few years, providers were still shocked by the company’s recent announcement that it would stop selling certain respiratory products.  Philips on Jan. 25 announced that it would discontinue selling 19 products in the U.S., including items subject to a recall, like the Trilogy 100/200/202 portable home ventilators. The company will service many of the products until Jan....

CPAP, Philips Respironics, Recall, ventilators


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Roy Jakobs

Vendors

Philips agrees to terms of consent decree 

January 29, 2024HME News Staff

AMSTERDAM – Philips has agreed on the terms of a multi-year consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory care devices, providing clarity and a roadmap to demonstrate compliance and to restore the business, the company says.  In the U.S., Respironics will continue to service sleep and respiratory care devices already with health care providers and patients, and supply accessories (including patient...

Consent Decree, Philips, Philips Respironics, Recall


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Mick Farrell

Vendors

ResMed on mask recall, big tech and demand-gen

January 26, 2024Liz Beaulieu, Editor

SAN DIEGO – ResMed CEO Mick Farrell said a recall of its CPAP masks with magnets did not impact the company’s sales for the second quarter ended Dec. 31, 2023.  ResMed in November issued an urgent field safety notice to patients detailing possible interference with its AirFit and AirTouch masks and certain medical devices; the company in December then announced a voluntary global field action to update its guides. The U.S. Food and Drug Administration in January classified...

CPAP, CPAP Mask, Mick Farrell, Recall, ResMed


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Vendors

FDA classifies ResMed recall

January 15, 2024HME News Staff

WASHINGTON – The U.S. Food and Drug Administration has classified ResMed’s recall of CPAP masks with magnets a Class I recall, the most serious type.  ResMed in November issued an urgent field safety notice to patients detailing possible interference with its AirFit and AirTouch masks and certain medical devices. Then the company in December announced a voluntary global field action to update its guides.  “ResMed is recalling these masks to update the labels, add...

Recall, ResMed


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Vendors

FDA releases alert on Philips BiPAP machines

August 30, 2022HME News Staff

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...

Food & Drug Administration (FDA), Philips, Recall


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Philips ‘recovery subject to consent decree’ 

Vendors

Philips ‘recovery subject to consent decree’ 

July 29, 2022Liz Beaulieu, Editor

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...

Consent Decree, Philips, Recall


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Also Noted

AAH to payers: Temporarily relax CPAP requirements 

May 31, 2022HME News Staff

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...

AAHomecare, CPAP, Patient compliance, Recall, supply chain challenges


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Frans van houten

Vendors

Philips on recall: ‘We are progressing very well’

April 29, 2022Liz Beaulieu, Editor

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...

CPAP, Philips Respironics, Recall


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