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.
Dutch healthcare giant now expects recall to affect around 5.2 million CPAP devices, says supply-chain woes have weighed on sales.
The company intends to complete the repair and replacement programs within approximately 12 months.
RT: The new facial scanning system analyzes each patient’s anatomy to recommend a more precise CPAP mask size.
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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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The obstructive sleep apnea treatment gains more attention after one of the largest positive airway pressure device makers issued a recall.
Read MoreNBC 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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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 MoreThe FDA has provided answers to frequently asked questions related to the Philips CPAP, BiPAP, and ventilator recall.
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Following a global recall of its CPAP and sleep care machines, Philips posted a decline in sales for that segment’s wider connected care portfolio.
Read MorePhilips’ actions, according to the complaints, constitute breaches of warranty as well as violations of state consumer protection statutes and other laws.
Read MoreBoston Globe: Among the most serious allegations made in the lawsuits is that Philips failed to disclose the defect as soon as it knew about it.
Read More“Prolonged exposure to these chemicals is worrisome, particularly since many people using CPAP and BiPAP already have underlying asthma and other respiratory diseases.”
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The American Academy of Sleep Medicine has released a webinar on how the Philips device recall will impact vulnerable patients, including pediatrics and those on ventilators.
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The American Academy of Sleep Medicine asks CMS and private payors to suspend the 90-day adherence rule for PAP therapy in the wake of the Philips recall.
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Panthera has issued a statement saying its digital production process allows for increases in production capacity for its custom-made D-SADs while maintaining 10-day turnaround times for the devices.
Read MoreReport any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.
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A lawsuit has been filed against Philips to protect consumers harmed by the company’s recalled CPAP machines which may increase users’ risk of cancer.
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