Federal regulators are heightening their warning about devices made by Philips Respironics used to treat obstructive sleep apnea, saying the products "may cause serious injuries or death." Philips recalled more than 5 million continuous positive airway pressure (CPAP) machines in June 2021 because ...
Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga. FDA’s...
而在2024年1月底,飞利浦伟康(飞利浦睡眠和呼吸护理业务,Philips Respironics)宣布,由于正在努力遵守与美国FDA达成的和解,未来几年内将不会在美国销售新的睡眠呼吸暂停(Sleep Apnea)治疗设备。 2024 年 4 月 9 日,联邦地方法院发布了针对飞利浦伟康 (Philips) 的关于在美国地区停售呼吸机相关产品的同意令。同意令包括...
Today, the FDA provided an update onmedical device reportsit received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announ...