LIFELINE AED

Model DDU 100A-Software versions earlier than version 2.002

Cardiovascular Devices

3

No

Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.

Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)

Press release: Alert on voluntary recall and corrective action by Defibtech on semi-automatic external defibrillators

Cardiovascular Devices

3

No

Worldwide distribution: USA (nationwide) and countries including: AUSTRALIA, AUSTRIA , BAHRAIN, BRAZIL, CANADA, CHILE, CHINA , CYPRUS, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA, REPUBLIC OF LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND URUGUAY.

Defibtech Lifeline AED and ReviveR AED, || Model: DDU-100 Series AEDs || Software version 2.004 or earlier || The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.

Model Catalog: DDU-100E (Lot serial: S/N 112001001 - 112002242); Model Catalog: DDU-100A (Lot serial: S/N 112001001 - 112002242); Model Catalog: DDU-100E (Lot serial: S/N 101001000 - 101025955); Model Catalog: DDU-100A (Lot serial: S/N 101001000 - 101025955); Model Catalog: DDU-100A (Lot serial: S/N 116001000 - 116001178); Model Catalog: DDU-100E (Lot serial: S/N 116001000 - 116001178); Model Catalog: DDU-100A (Lot serial: S/N 126000975 - 126001007); Model Catalog: DDU-100E (Lot serial: S/N 126000975 - 126001007)

Cardiovascular Devices

Debiftech DDU-100 Series AED (Lifeline)

Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.

Cardiovascular Devices

3

No

Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.

Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. || The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.