Devices

Device Recall Philips HeartStart XL Defibrillator/Monitor

Model / Serial
Serial number range: USO1100100 - USO1100372, USN1100376 - USN1100960, USD1100961 - USD1101095, US11201096 - US11201186, US21201187 - US21201239, US31201240 - US31201537, US41201538 - US41201585, US51201586 - US51201721, US61201722 -US61201924, US71201925 - US71202048, US81202049 - US81202168, US91202169- US91202514, USO1202515 - USO1202990, USN1202991 - USN1203537, USD1203538- USD1203968, US11303969 - US11303972
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.
Product Description
Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290 || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
Manufacturer
Philips Healthcare Inc.
1 Event
- Recall of Device Recall Philips HeartStart 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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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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