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Terminated

Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 9142

FDA Recall Z-0990-04 · Posted 2004-07-20

Recalling FirmCardiac Science, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-05-04
Date Terminated2005-11-18

Reason for Recall

Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.

Firm Action

A recall letter, dated May 10, 2004, stated that a replacement battery is enclosed with the letter, and instructed consignees to install the new battery in their defibrilllator and return the old battery.

Root Cause

Other

Distribution Pattern

The batteries were distributed with the defibrillators nationwide in the United States and to foreign consignees in Europe, Asia, Latin America, the Middle East and Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031987POWERHEART 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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