Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Philips: It Will Take 12 Months To Repair And Replace Recalled Sleep, Ventilator Devices

Executive Summary

Royal Philips will begin this month the unenviable task of repairing and replacing millions of BiPAP, CPAP and other mechanical ventilator devices that were recalled by the manufacturer in June. The effort will take a full year, Philips says.

You may also be interested in...



Philips Admits New Issues In Reworked Ventilators

A silicone foam that replaced hazardous polyurethane in some reworked Philips Trilogy ventilators could separate from the unit and block air flow; additionally, particles have been found in ventilator air pathways. 

Escalation: FDA Wants Philips To Repair, Replace Or Give Refunds For Recalled Breathing Machines

The US FDA is weighing whether to force the embattled company to repair, replace or refund recalled BiPAP, CPAP and other mechanical ventilator devices. Philips Respironics may attend an “informal hearing” before the agency decides.

Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices

Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT144414

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