Z-0829-2016Class II

9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and...

Name: Z-0829-2016 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and...
Creator: Cardiac Science Corporation
Published: 2016-01-14
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2016-01-14 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation... on 2016-01-14. FDA classified it as Class II and gives the reason as "Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0829-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-14
Posted: 2016-03-09
Terminated: 2016-12-21
Recalling firm: ZOLL Medical Corporation
Product: 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. This is normal behavior when the impedance limit is exceeded. The high impedance electrodes require replacement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardiac Science sent an Urgent: Voluntary Medical Device Recall letter dated January 2016 starting on January 14, 2014. The letters were either addressed to Distributor or Customer. The letter described the problem and the product involved in the recall. Requested consignees to replace any electrodes from the lot 141125-02 and return them to Cardiac Science. Furthermore, it advised consignees to contact their customers or members of their facilities who need to be made aware by providing a copy of the notification letter and replacement electrodes if they were a distributor. For questions contact Cardiac Science Technical Support at 1-800-426-0337, option 1 in USA or +1-262-953-3500 OUS or via e-mail a9131cardiacscience.com. For questions regarding this recall call 800-426-0337.
Quantity in commerce: 10,943
Distribution: Worldwide Distribution - US all states including PR except ND & RI. International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
Product codes and lots: Lot No. 141125-02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0829-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0829-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-22

Product code MKJ

K102496Class IIIPowerheart AED G3 Semi-Automatic, Powerheart AED G3 Automatic, Powerheart AED G3 Pro, Powerheart AED G3 PlusCardiac Science Corporation / cleared 2011-06-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)