Philips Recalls Panorama 1.0T HFO MRI System for Explosion Risk
Philips is recalling the Panorama 1.0T HFO due to risk of explosion during a quench procedure caused by excessive pressure buildup.
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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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FDA: Philips Ventilator Recall Report Numbers Increasing
The FDA received an additional 6,000 medical device reports January 1, 2023-March 31, 2023, related to PE-PUR foam used in Philips ventilators and other devices recalled in June 2021.
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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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