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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 ...
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 ...
It is important that third parties reading Warning Letters understand that matters that FDA Warning Letters describe may have been subject to subsequent interaction between the FDA and the recipient that may have changed the regulatory status of the issues discussed. [6] (See the "External links" section below for electronic access to Warning ...
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 ...
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 ...
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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 ...