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The company also added that the recall doesn’t affect Philips’ ongoing efforts to repair and replace all of the CPAP and BiPAP machines and other ventilators included in the initial 2021 recall.
Philips sent updated instructions after disclosing problems last year with an alarm that can interrupt treatment for people with obstructive sleep apnea or respiratory insufficiency.
FDA warns that Philips has fully fixed 'considerably' fewer recalled devices than online tally may suggest ...
Philips originally notified users of this recall on February 10, instructing them to locate their CPAP/BiPAP device's serial number, contact providers about manual pressure resets, and to continue ...
The agency, in a statement issued last week, said it has received more than 116,000 reports about the breathing devices — BiPAP and CPAP machines — over nearly three years.
The US Food and Drug Administration issued a Class I recall Friday, the most serious type of recall, for certain Philips Respironics DreamStation1 CPAP machines.
The agency, in a statement issued last week, said it has received more than 116,000 reports about the breathing devices — BiPAP and CPAP machines — over nearly three years.
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