Court Restricts Philips Respironics CPAP and BiPAP Production
A consent decree of permanent injunction was issued against Philips Respironics, halting production of their sleep therapy devices.
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Philips Stops Selling Respiratory Products in the U.S.
Philips announced that it would stop selling CPAP or BiPAP sleep therapy devices and other respiratory care devices in the U.S.
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Senators Call for Review of ‘Ineffective’ FDA Recall Policies
Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA’s policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.
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FDA Issues Safety Alert for Philips CPAP Machine
The FDA has issued a safety alert regarding Philips Respironics’ DreamStation 2 CPAP machines due to reports of safety issues, including fire, smoke, burns, and overheating, and is working with the company to address the problem and provide safety recommendations to users.
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Philips Issues New Urgent Medical Device Correction for Ventilators
Philips Respironics issued an Urgent Medical Device Correction Letter regarding a problem for certain ventilators that could harm patients.
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