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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 ...
Philips spokesperson Steve Klink said in a statement that the recall was "a complex undertaking because of the sheer volume of devices to be remediated, and the outreach to every individual patient."
Philips was recalling some models of the Panorama 1.0T HFO device in the U.S. due to risk of explosion during a "quench procedure" caused by excessive buildup of helium gas. During the procedure ...
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 ...
Philips' recall of BrightView Imaging Systems, used for single photon emission computed tomography (SPECT) scan, is to correct the faulty component and not a product removal, the health regulator ...
Continuous positive airway pressure (CPAP) is a form of positive airway pressure (PAP) ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person.
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.