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Philips stopped producing and selling the product line in 2014, according to the company. The company is also grappling with the fallout of a global recall in 2021 of millions of respirators used ...
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 said it had some 2.6 million devices registered for the recall in the U.S. — which it said represented the "vast majority" of affected devices nationwide — but was continuing to try to ...
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 ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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 ...
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.
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