Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall
[Updated 07/19/2010] Since FDA issued its last communication on this recall on April 27, 2010, Cardiac Science Corporation has developed a replacement plan for high risk and/or frequent use facilities. The company has prioritized the replacement of the devices into two groups:
First Tier: Police, Fire and Ambulance
Second Tier: Hospitals Medical Clinics, Assisted Living Facilities, and Dialysis Centers
Cardiac Science will contact all users to determine the specific replacement schedule for each user. Follow the company’s instructions for replacement. FDA recommends that all other users, including Home Users and Public Access Defibrillation Programs, and facilities with only one external defibrillator not belonging to one of the First or Second Tier replacement groups, take the following steps:
- Obtain the software upgrade from the Cardiac Science website that corresponds with your external defibrillator.
- While these software upgrades detect some failures but not others, Cardiac Science external defibrillators may be used if needed, as the units are likely to still be able to deliver the necessary therapy. The consequences of not attempting to defibrillate a patient outweigh the remote possibility that some of these devices may fail.
- If the device indicates that service is needed, please contact Cardiac Science for repair or replacement of the device.
- Use an alternate external defibrillator if available, until the Cardiac Science Corporation external defibrillators have been repaired or replaced.
Updated recommendations can be found in the 07/19/2010 Medical Device Update.
[UPDATED 04/27/2010] This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects.
Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
[Posted 03/08/2010] Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a Class 1 recall of automated external defibrillators (AED). These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death. List of affected models includes:
- Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
- CardioVive 92531, 92532, 92533
- NK 9200G, 9231
- Responder 2019198 and 2023440.
The affected AEDs were manufactured and distributed between August 2003 and August 2009.
[07/19/2010 - Update on Defective Cardiac Science Corporation External Defibrillators - FDA]
[04/27/2010 - Update on Defective Cardiac Science Corporation External Defibrillators - FDA]
[03/08/2010 - Recall Notice - FDA]