Service Announcements & Upgrades
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
Models Affected: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, CardioLife 9200G, 9231, and the GE Responder and Responder Pro.
Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy.
This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies.
Each affected AED should be returned to Cardiac Science for correction as soon as possible.
Cardiac Science is contacting affected customers to facilitate the return of the AEDs to the factory. All affected AEDs will be corrected at no charge to the customer.
Customer can contact Cardiac Science at 1.888.402.2484 (in the United States). Outside the United States, customers can contact us at +1.425.402.2482 or speak with the local Cardiac Science representative. Customers can also email Cardiac Science at firstname.lastname@example.org for more information.
Serial Number SearchTo determine if a device is affected by this voluntary medical device correction, please enter one or more serial numbers in the box below. Locate the serial number on the back of your device. Serial numbers are marked SN and contain no letters.
Serial Number Entry:
Use comma "," to separate multiple serial numbers.
Result will show below
1. Fill in this form to download the software package onto your computer.
2. Install the software update from your computer onto your AED
Print out Installation + Verification Tips if you haven't already.
You can find additional resources you need to perform this update at the top right of this page.
To the left is a silent video that follows a user through the update process.
Note: To perform the update, you will need to connect the AED serial communications cable that came with your AED at the time of purchase between your computer and the affected AED. If you can not find your cable, contact Customer Support (below) to order a replacement.
3. Confirm each update individually to Cardiac Science
You need to send us a confirmation text file for each AED you update. This is a mandatory step. We will continue to follow up with you until we get this confirmation for each affected AED in your possession.
You can send your confirmation three ways.
Preferred / Easiest: Follow the steps at the end of the software update. This will send all the required information.
Less preferred: Confirm your software update using this online confirmation form. You will have to attach each confirmation text file alongside the appropriate box on the form.
Least preferred: Reply by mail, fax, or email by downloading this PDF form. You will have to include a print out or scan for each confirmation text file.