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
UsernamePublicRestriction

GE Healthcare Recalls Respiratory Monitors Over Display Issue

It’s the second time in a month that the FDA has taken action related to the safety of GE’s CARESCAPE product line

Executive Summary

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.

You may also be interested in...



GE Monitoring Station Vulnerability Could Let Hackers Turn Off Critical Patient Alarms

US regulators and GE have notified health-care providers that the company’s nurse bay monitoring stations could be attacked by malicious hackers to turn off critical alarms that are intended to alert caregivers when a patient is in a critical state.

Class I Recall On Abbott Coronary Catheters

The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.

US FDA Deems MiniMed Safety Issues Class I Recall

Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.

Topics

Related Companies

UsernamePublicRestriction

Register

MT126208

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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