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Recall Observatory FDA recall evidence

Device product

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

Z-0871-2013

January 28, 2013

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 64201
Status
Terminated
Classification
Class II
Quantity
3785 units
Official record key
device-enforcement:Z-0871-2013

Official wording

Reason: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use