Pink Sheet 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.

Menu

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
My View
Tags:
Medical Device

Cardiac Science warns customers about faulty AEDs

This article was originally published in Clinica

  • News
  • Joseph Harvey  

Executive Summary

Cardiology technology specialist Cardiac Science has initiated a worldwide voluntary field corrective action for certain models of its Powerheart and CardioVive automated external defibrillators (AEDs), manufactured between August 2006 and March 2007. The Bothell, Washington-based company has received two complaints about a defect in the devices' software which causes it to go into ‘service required’ mode while attempting to provide defibrillation, thereby rendering it inoperable. Cardiac said that it is providing user-installable software update to affected customers and distributors. The firm expects this action to lead it to incur a pre-tax charge of $0.8-1m in the third quarter of 2008.

Table

View full table

Topics

Tags:
Medical Device
Latest Headlines

Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer’s Hemophilia B Gene Therapy

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

See All
UsernamePublicRestriction

Register

MT040903

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

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