Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptom

FDA device recall Z-3265-2011 · posted 2011-09-19 · Terminated

Recall details

Recalling firm

Cardiac Science Corporation

Reason for recall

Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro

Action taken

Cardiac Science began mailing out the recall notification letter on August 1, 2011, to all their US consignees via USPS first class mail. Cardiac Science's distribution partners will receive a notification letter and be provided with a template letter to send to their customers directly. CSC remind owners/operators of the Powerheart AED devices to check the status of of the AED every day to ensure it is Rescue Ready, and perform the regularly schedule maintenance as outlined in the Powerheart AED "Operator and Service Manual" provided with every AED. Customers can call Cardiac Science at 800-426-0337 or e-mail at aed205@cardiacscience.com.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

195,739 units in US

Distribution

Worldwide Distribution - US (nationwide) This action applies only to domestic

Date initiated

2011-06-30

Date posted

2011-09-19

Date terminated

2014-02-13

Location

Bothell, WA

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