Medtech Insight is part of the Business Intelligence Division 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

Apnea monitor recall

This article was originally published in The Gray Sheet

Executive Summary

FDA labels Philips/Respironics' April recall of its SmartMonitor 2 infant apnea monitor a Class I action May 18, signifying the highest level of risk. The firm instructed medical supply companies on April 23 to return all units of the product, including those already shipped to patients, in response to a finding that the device may fail to sound an alarm if there is a temporary interruption of breathing or low heart rates. SmartMonitor 2 is used for continuous monitoring of respiration and heart rate in infants at home or in the hospital
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT027466

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