Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

More Headaches For Philips As FDA Labels Another Ventilator Recall As High-Risk Class I

Executive Summary

The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.

You may also be interested in...



It’s Class I For June Recall Of Philips Breathing And Ventilator Devices

The US FDA on 22 July designated a recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices as high-risk class I.

Polyurethane Foam Problems Nudge Philips To Recall Certain Sleep, Mechanical Ventilator Devices

Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.

Compliance Corner: Don’t Sign (Or Even Hear) That Affidavit!

Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.

Topics

UsernamePublicRestriction

Register

MT144299

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel