Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button

FDA device recall Z-1248-2010 · posted 2010-04-06 · Terminated

Recall details

Recalling firm

Cardiac Science Corporation

Reason for recall

A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.

Action taken

The firm began initial notification on 2/3/2010 by sending letters to all affected consignees via USPS certified mail (domestic) and FedEx (international). Also on 2/3/2010 the firm issued a global press release and posted recall information on their website. Customers are instructed to remove their affected units from service, and have been given instructions for returning their affected devices. Replacement AED(s) will be sent as they are available. For questions, please contact the firm's Cardiac Science Support at 1.888.402.2484 or. AED195@cardiacscience.com to arrange for replacement(s).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

1

Distribution

Distributed to health care and emergency medical personnel and US Gov't/Military in the US and the following 44 countries: AUSTRALIA, BELGIUM, BELIZE, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, DENMARK,

Date initiated

2010-02-03

Date posted

2010-04-06

Date terminated

2011-12-08

Location

Bothell, WA

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