Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E

FDA device recall Z-1057-2012 · posted 2012-02-27 · Terminated

Recall details

Recalling firm

Cardiac Science Corporation

Reason for recall

The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy.

Action taken

Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at aed210@cardiacscience.com to arrange delivery of the shipping materials. Customers can also visit www.cardiacscience.com/aed210 for more information about AEDs affected by this recall.

Root cause

Process control

Status

Terminated

Product code

MKJ

Quantity affected

11,019 units (6142 units in the US and 4877 units international)

Distribution

Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France

Date initiated

2012-01-13

Date posted

2012-02-27

Date terminated

2013-09-27

Location

Bothell, WA

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