Z-1248-2010

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

Name: Z-1248-2010 Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a...
Creator: Cardiac Science Corporation
Published: 2010-02-03
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2010-02-03 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver... on 2010-02-03. The reason FDA records is "A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1248-2010
Status: Terminated
Initiated: 2010-02-03
Posted: 2010-04-06
Terminated: 2011-12-08
Recalling firm: ZOLL Medical Corporation
Product: Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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. [email protected] to arrange for replacement(s).
Quantity in commerce: 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, EGYPT, FRANCE, GERMANY, GRENADA, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TRINIDAD, AND GREAT BRITAIN.
Product codes and lots: SERIAL NUMBER: 4048171

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)