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Jun. 15—Medical equipment company Philips has issued a recall on some products to address possible health risks associated with a foam component meant to help reduce noise. The polyester-based ...
The Dutch medical devices maker started the process on March 29 and has recalled 73,000 devices in the United Sates. Philips was recalling the ventilators after detecting contaminants such as dust ...
Over 550 devices are being corrected by Philips in the United States, the FDA said. The company, which stopped producing and selling the BrightView product in 2014, said the financial impact of ...
The medical technology and equipment giant Philips has recalled some of its ventilators and CPAP machines due to a form piece that could potentially become toxic and cause cancer in its users.
Only in 2021 did Philips recall the machines, which had been delivered across the United States and many other countries. Over 3,700 complaints across more than 11 years were held back from the FDA, which device makers are required to do so within 30 days of reports of patient injuries in addition to investigating them.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Device Warning Letters (except those issued to IRBs, clinical investigators, sponsors, and monitors involved in clinical trials) include the notice, "Federal agencies are advised of all Warning Letters about devices so that they may take this information into account when considering the award of contracts." [3]
AMSTERDAM (Reuters) -Philips shares surged 35% early on Monday as the medical devices maker announced a smaller-than-expected settlement to resolve claims over recalled breathing devices in the ...