91 More Reports of Death in Philips Recall-Related Reporting
The FDA updated its safety communication on the Philips’ recall to include reporting of medical device reports received from August 1 to October 31, 2022.
Tag: Philips Respironics
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Philips Recalls Specific CPAP, BiPAP Masks with Magnets
The FDA announced the recall of certain Philips Respironics CPAP and BiPAP masks due to a safety concern involving magnets.
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FDA Proposes Philips Offer Refunds as Option in CPAP Recall
Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price.
FDA Orders Philips Respironics to Notify Patients of Recall for CPAP Devices, Ventilators
“The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate,” the agency wrote in a news alert.
Read MorePhilips Hit By Supply Chain Woes, Recall Fallout Continues
Shares in Philips plunged 15% on Wednesday, their worst intra-day drop in over 20 years, after the Dutch health technology group warned supply chain woes would hit profits and a ventilator recall needed to be expanded.
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Philips: Sleep Apnea Machine Recall Costs Grow
Dutch healthcare giant now expects recall to affect around 5.2 million CPAP devices, says supply-chain woes have weighed on sales.
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CPAP Recall: Philips Releases Update on Health Risk
A research assessment looked at the levels of VOCs identified in first-generation DreamStation devices.
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SoClean Files Lawsuit Against Philips Over ‘False And Misleading Statements’ Regarding CPAP Product Recall
SoClean alleges that Philips made false and misleading statements regarding ozone cleaners that have had a negative impact on SoClean’s business.
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Connecticut Attorney General Urges FDA to Expedite Philips CPAP Replacement
AG William Tong has called on the company to provide replacement machines, reimbursement, and repair guidance.
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FDA Updates FAQs on Philips Recall
Get answers to: Can Philips Respironics face any kind of fines or enforcement action by the FDA over its handling of this recall? And: Are the product codes for CPAP and BiPAP machines on the FDA’s device shortage list?
Read MoreGetting the Right CPAP Mask Fit with the Philips Respironics Mask Selector
RT: The new facial scanning system analyzes each patient’s anatomy to recommend a more precise CPAP mask size.
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Philips Starts Repair & Replacement Program of First-Gen DreamStation Devices in United States
The company intends to complete the repair and replacement programs within approximately 12 months.
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CPAP Recall: Philips to Start Replacing Millions of Devices
Philips announced Wednesday that it would begin the process of replacing millions of CPAP devices in the United States after a recall in June left many patients without sleep apnea treatment.
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Philips: ‘Bacteria Filters Should Not Be Used on CPAP/Bilevel Devices as a Means of Mitigating Risk of PE-PUR Foam’
New supplemental information released by Philips strongly advises against using bacteria filters for this purpose.
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Will More Sleep Apnea Patients Turn to Oral Appliance Therapy in the Wake of the Philips CPAP Recall?
The obstructive sleep apnea treatment gains more attention after one of the largest positive airway pressure device makers issued a recall.
Read MoreMany Americans Unaware of When Products Are Recalled
NBC 7 looked at the recent Philips CPAP recall and how it illuminates an issue with the larger system of recalls at large.
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Philips CPAP Recall Leaves Truck Drivers with Sleep Apnea Between a Rock and a Hard Place
In the wake of the Philips CPAP recall, an Oregon-based truck driver has filed a class action lawsuit due to not being able to work while not being treated for sleep apnea.
Read MoreFAQs on the Philips CPAP, BiPAP, and Ventilator Recall
The FDA has provided answers to frequently asked questions related to the Philips CPAP, BiPAP, and ventilator recall.
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