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The recall extends to 32 devices of the Model 3028 IPG. Inspire Medical Systems is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect.
In June 2021, the FDA first announced the recall of Philips Respironics BiPAP and CPAP devices—which are worn overnight while someone sleeps—as well as ventilators, saying the polyester-based ...
The California-based medical device maker started the recall process on Nov. 20 and has recalled over 20 mill. ... (CPAP) masks, AirFit and AirTouch, due to possible magnetic interference with ...
A 2021 recall of Philips breathing devices is related to 561 deaths, the U.S. Food and Drug Administration said Wednesday. 561 deaths linked to recalled Philips sleep apnea machines, FDA says Skip ...
Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep.
The implant may be configured to best accommodate the patient's comfort and sleeping habits (e.g., set a delay based on sleep latency). The hypoglossal nerve stimulator implantable pulse generator battery life typically lasts 8–12 years, after which the implantable pulse generator may be safely replaced with another surgery. [8]
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 ...
Matthew Stone, 61, was using a Philips CPAP machine for sleep apnea, but fell back on an older device from another manufacturer due to the recall. (Allen J. Schaben / Los Angeles Times)