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Medical Device Recall

All articles tagged with #medical device recall

health-business1 year ago

"Philips Ordered to Overhaul Sleep Apnea Device Manufacturing After Recall"

Philips, responsible for a global recall of sleep apnea machines due to defective foam, has been ordered to overhaul its manufacturing and quality control systems by federal officials. The company must also continue to replace, repair, or provide refunds to all U.S. customers affected by the defective devices. The settlement comes after years of delays in addressing the issue, with lawsuits filed by affected individuals in multiple countries. The FDA found instances where Philips was aware of the problem with its foam years before the recall, prompting the agency to order clearer information about the health risks of the products and increased outreach to affected customers.

via The Associated Press|
#cpap-machines#fda#health-business
health-business1 year ago

"Philips Agrees to Overhaul Manufacturing After Sleep Apnea Machine Recall"

Philips, responsible for a global recall of sleep apnea machines due to defective foam, has been ordered to overhaul its manufacturing and quality control systems by federal officials. The company must also continue to replace, repair, or provide refunds to all U.S. customers affected by the faulty devices. The settlement aims to address one of the biggest medical device recalls in history, which has been ongoing for nearly three years, and requires Philips to hire independent experts to vet the changes and meet safety requirements before resuming production at U.S. facilities.

via Yahoo! Voices|
#cpap-machines#fda#health-business
health-business1 year ago

"FDA Links 561 Deaths to Recalled Philips Sleep Apnea Machines"

The FDA has reported 561 deaths linked to recalled Philips devices used to treat sleep apnea and other breathing disorders, with over 116,000 medical device reports of foam breaking down in the machines. Philips has agreed to a $479 million settlement and will stop selling the machines in the U.S., while continuing to service existing ones. Users affected by the recall can file claims for financial losses, and the deadline for submissions is August 9, 2024. The settlement does not affect claims for personal injuries or medical monitoring relief, and Philips denies conclusive data linking the devices to the reported deaths.

via CBS News|
#cpap-machines#fda#health-business
healthcare2 years ago

"Managing the Aftermath: Navigating the Philips Breathing Machine Recall"

Philips Respironics' recall of its DreamStation breathing machines and other sleep apnea devices has left millions of patients waiting for replacements due to foam inside the machines potentially releasing carcinogenic materials. A documentary film captures the experiences of patients and doctors navigating the fallout of the recall, highlighting the difficult choices faced by patients and the impact on their lives. The film aims to humanize the individuals affected and raise awareness about the implications of the recall.

via ProPublica|
#documentary-film#healthcare#medical-device-recall