Devices

Batteries for XL Defibrillator/Monitor

Model / Serial
HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.
Product Description
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries || The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Manufacturer
Philips Healthcare Inc.
1 Event
- Recall of Batteries for XL Defibrillator/Monitor

Manufacturer

Philips Healthcare Inc.

Manufacturer Address
Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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