Is there a recall on the Philips Respironics ventilator?

Is there a recall on the Philips Respironics ventilator?

On June 30, 2021, the FDA issued a safety communication: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks. The FDA understands the concerns from people using these affected devices.

Why choose Philips Respironics for sleep apnea?

Examining sleep apnea. Philips Respironics offers innovative products for sleep and home respiratory care as well as medical education and value-added programs to help you navigate a rapidly changing industry landscape, and in the interest of maximizing both clinical and business success.

Why choose philphilips Respironics masks?

Philips Respironics masks are designed to support enhanced NIV. From comfort for your patients to ease of use for you, our interfaces are specially designed to meet the rigors of acute care environments. Delivering exceptional NIV 2 Respironics hospital NIV asks 452299101601.indd 2 24/02/14 12:22 Respironics hospital NIV masks 3

Will Philips Respironics replace the sound abatement foam with a new material?

Q: Philips Respironics has stated they “will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances.” Is the FDA reviewing Philips Respironics submission for clearance of the new foam?

Are there any recalls on Philips devices for sleep apnea?

877-907-7508 On June 14, 2021, Philips issued a recall notification for the United States for specific affected ventilation and sleep apnea devices. The notification informs patients, users and customers of potential impacts on patient health and clinical use related to this issue.

What is Philips Respironics’ mitigation strategy?

A: As the medical device manufacturer, Philips Respironics has a responsibility not only to ensure the manufacture of safe and effective devices, but also to establish an appropriate mitigation strategy to reduce public harm in the event of device failure or defect.