Z-3265-2011

Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims...

Name: Z-3265-2011 Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims...
Creator: Cardiac Science Corporation
Published: 2011-06-30
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2011-06-30 / Terminated / root cause: design

FDA source

Cardiac Science Corporation began a recall of Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are... on 2011-06-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3265-2011
Status: Terminated
Initiated: 2011-06-30
Posted: 2011-09-19
Terminated: 2014-02-13
Recalling firm: ZOLL Medical Corporation
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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
Root cause tag: design
FDA root cause: Device Design
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].
Quantity in commerce: 195,739 units in US
Distribution: Worldwide Distribution - US (nationwide) This action applies only to domestic
Product codes and lots: Serial numbers: 022805, 031605, 303024, 322627, 322644, 328877, 900034, 900055, 900061, 900110, and 972196. Serial numbers Ranges: from 900134 through 903240; from 329024 through 394573; from 400001 through 4049272; from 4100002 through 4370573; from 92532-0000501 through 92532-0001310; and from 92533-0000000 through 92533-0001340.

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)