Power Heart Automatic External Defibrillator, Model 9210 RD
FDA Recall Z-1034-04 · Posted 2004-07-20
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Recalling FirmCardiac Science, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2004-05-24
Date Terminated2005-11-18
Reason for Recall
Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
Firm Action
A recall letter, dated May 24, 2004, stated that a replacement AED is enclosed with the letter, and instructed consignees to replace their AED with the new one immediately and return the old AED.
Root Cause
Other
Distribution Pattern
The recalled AED units were distributed nationwide in the United States and to foreign accounts in Europe, Asia, Latin America, the Middle East, and Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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