the u.s. food and drug administration (fda) is alerting people who use philips respironics ventilators, bipap, and cpap machines and their health care providers that philips respironics has recalled certain devices (see table below) due to potential health risks. the pe-pur foam in the affected philips respironics cpap, bipap, and ventilator devices may: these issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage. in addition, on september 10, 2021, the fda updated the frequently asked questions about this recall on fda.gov: philips respironics cpap, bipap, and ventilator recall: frequently asked questions.
the fda is working with philips respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. the fda is working to assure philips respironics adequately evaluates the issue with the device, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company. the fda posted answers to frequently asked questions about this recall: philips respironics cpap, bipap, and ventilator recall: frequently asked questions.
the philips cpap recall includes the philips dreamstation and other popular cpap machines. the health risks come from sound abatement foam used to keep the machines quiet and reduce vibration. if you aren’t sure if your machine is affected, philips has set up a registration process that allows users and caregivers to look up the serial number of their device.
the fda recommends people using a recalled philips cpap machine talk to their medical provider to discuss their treatment options. currently, the fda doesn’t recommend that patients who received a repaired recalled cpap from philips stop using their machines with silicone foam. michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. drugwatch’s trusted legal partners support the organization’s mission to keep people safe from dangerous drugs and medical devices.
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date issued: . the u.s. food and drug administration (fda) is alerting people who use philips respironics ventilators, bipap, quick links best overall cpap machine: resmed airsense 10 autoset best budget cpap machine: devilbiss intellipap auto best portable cpap philips respironics recalled their cpap devices because degraded sound abatement philips recalled their cpap, bipap and ventilator devices in june 2021, cpap recall, cpap machines for sale, best cpap mask, resmed cpap recall 2021.
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