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Terminated

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.

FDA Recall Z-0829-2016 · Posted 2016-03-09

Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2016-01-14
Date Terminated2016-12-21
Product Quantity10,943

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102496POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUSCardiac Science Corporation · 2011-06-09

Official Source

View FDA Recall →

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

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