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Date: 10/9/2009

Title: Factory-Testing Corrective Action

Full Description:

Cardiac Science is conducting a voluntary correction of certain automated external defibrillators (AEDs) which may not have received complete testing prior to being shipped from the factory. Our test records indicate the fixture used to perform product final test may not have allowed for complete evaluation of the AED functionality. While there has been no reported field failure and our analysis indicated that the likelihood of this happening is remote, we will be providing affected customers with replacement devices and asking them to return their affected AEDs.

Customers with affected devices should keep their AEDs in service until they receive their replacement devices.

Quality is our top priority. We stand behind every product and service we provide, which is why we are taking this voluntary action. We do apologize for any inconvenience.

Additional information regarding the affected units is available within this Web page.

Serial number search

To determine if a device is affected by this voluntary corrective action, 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.

If your device status above indicates "NOT Affected," no further action is needed from you.

If your device status above indicates "Correction Needed," you will receive a replacement device.

If one or more of your AEDs is affected, you will receive written notification, as well as a phone call from an authorized Cardiac Science representative explaining that you have an affected device.

Upon contacting you, we will arrange to have a replacement AED shipped to your facility at no charge.

Once you have the replacement AED:

  • Place your new AED into service.
  • Remove the affected AED from service.
  • Remove and keep all accessories from the affected AED (battery, electrodes, carry bag, ready kit, etc.).
  • Return the affected AED without the battery to Cardiac Science per the instructions included with the replacement AED.

For questions regarding this voluntary field corrective action: