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

UK Sleep Apnea Monitor Recall Poses Logistic Challenges For Vital Signs

This article was originally published in The Gray Sheet

Executive Summary

Vital Signs should create a management plan to inform users how to monitor and correct settings for the firm's Breas AB CPAP PV10 sleep apnea ventilator, according to a UK Medical Device Alert

You may also be interested in...



Respironics Class I recall

Firm announces voluntary recall of 5,293 ComfortGel sleep apnea nasal masks distributed from Sept. 5-15 because some products were shipped without an exhalation port for carbon dioxide. Without the port, patients could experience oxygen deficiency or suffocation, the Murrysville, Penn. firm says Dec. 3. Respironics alerted FDA of the issue in September, and maintains that 82% of the recalled masks have returned with less than 3% affected. The company initiated a Class I recall for computer-controlled ventilators this summer (1"The Gray Sheet" July 7, 2003, In Brief)...

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT020818

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