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The FDA said it had received reports of people facing thermal issues such as fire, smoke, burns, and other signs of overheating while using Philips' DreamStation 2 CPAP machines.
Earlier this year, Dutch medical device maker Royal Philips reached a $1.1 billion deal to settle thousands of claims stemming from a recall in 2021 of millions of its breathing machines like ...
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
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 ...
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.
AMSTERDAM (Reuters) -The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the ...
Since the recall, the FDA has received more than 116,000 reports of actual or suspected incidents of foam breaking down in the machines and 561 deaths reportedly associated with (or suspected to ...
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 ...
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