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

Class I Recall For GE Healthcare CARESCAPE Ventilator

Executive Summary

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

You may also be interested in...



GE Healthcare Recalls Respiratory Monitors Over Display Issue

Some models of GE Healthcare’s CARESCAPE respiratory modules are being recalled because they may incorrectly display a patient’s blood oxygen level. The US FDA has labeled the action a high-risk class I recall.

Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

OTC Sales Of Hearing Aids For Mild To Moderate Loss Allowed Under US FDA Final Rule

After requirement from Congress and push from President Biden, FDA establishes regulatory category for hearing aids to allow US consumers with mild to moderate hearing loss to purchase the devices without a prescription or prior exam.

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT145565

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