FDA Updates Injury, Death Reports from Ventilator Inoperative Alarm-Related Recall
The recall involves correcting devices and does not involve removing them from where they are used or sold.
Tag: bipap
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After CPAP Recall, Philips Must Institute New Safeguards in Agreement With U.S. Justice Department
Three years after its CPAP recall, Philips has reached an agreement with the US Justice Department to institute new safety measures.
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Philips Recalls Certain Reworked DreamStation CPAP, BiPAP Machines
This recall is for certain reworked DreamStations that were also recalled in June 2021.
Philips: ‘99%’ of Replacement Sleep Therapy Devices Produced
Philips Respironics provided an update on the field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
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AdaptHealth Names Next CEO
AdaptHealth has announced the appointment of a new CEO who will assume the role in September and spearhead the company’s initiatives to improve at-home care.
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40 More Deaths Reported in Philips Recall
The FDA updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.
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Philips Completes Risk Assessments for Recalled CPAPs and BiPAPs
Royal Philips’ CEO says the third-party risk assessments for the sleep therapy devices under the June 2021 recall are “positive and reassuring.”
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AdaptHealth Q1 Results Highlight Strong Sleep Business, Leadership Change
The company’s CEO says AdaptHealth is seeing stabilization post-pandemic and post-Phillips recall.
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Philips CEO: Resolving Recall Remains ‘Our Highest Priority’
Philips provides an update on field action for specific sleep therapy and ventilator devices involved in the company’s ongoing recall.
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FDA: Philips Respironics Recall Classified as Level I
The new classification comes after the FDA announced a Philips Respironics recall of certain BiPAP and CPAP masks due to a serious safety concern related to magnetic headgear clips that may cause harm to people who have implanted medical devices.
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