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

Physio-Control handed class I notice for defib recall

This article was originally published in Clinica

Executive Summary

The US FDA has classified Physio-Control’s recall of nearly 43,000 units of its LIFEPAK 20 and 20e external defibrillators and monitors as a class I notification, the most severe recall classification. The recall, which was initiated on 27 May, was caused by a possible battery malfunction on defibrillators manufactured prior between 31 July 2002 and 19 September 2007 and have been distributed worldwide. Minneapolis, Minnesota-based Physio-Control, a Medtronic subsidiary, said that the malfunction could delay the delivery of therapy and may potentially cause injury of death. The company said that there was one unconfirmed adverse patient event connected to the LIFEPAK products, over the eight-year product life. Physio-Control said it is currently notifying all its customers both in and outside the US and it plans to update all affected power supplies at no charge, during one field service update at the customer site.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT095068

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