FDA Device recall Z-0829-2016
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131… by Cardiac Science, citing 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, th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0829-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-14 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiac Science |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot No. 141125-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0829-2016%22
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