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Terminated

Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. Brand names: Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED.

FDA Recall Z-3265-2011 · Posted 2011-09-19

Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2011-06-30
Date Terminated2014-02-13
Product Quantity195,739 units in US

Reason for Recall

Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro

Firm Action

Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly. CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED. Customers can call Cardiac Science at 800-426-0337 or e-mail at [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide) This action applies only to domestic

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052161POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)Cardiac Science, Inc. · 2005-10-21K040438POWERHEART AED G3ACardiac Science, Inc. · 2004-07-01K031987POWERHEART AED G3, MODEL 9300Cardiac Science · 2003-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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