Terminated

Philips HeartStart XL+ Defibrillator/Monitor Model: 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. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.

FDA Recall Z-1107-2014 · Posted 2014-02-26

Recalling FirmPhilips Medical Systems, Inc.

Recall StatusTerminated

Product CodeMKJ

Date Initiated2014-01-24

Date Terminated2020-09-03

Product Quantity7157 units

Reason for Recall

HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling

Firm Action

Philips Healthcare issued a Customer Information Letter on January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers with an IFU Addendum titled: HeartStart XL+ Instructions for Use Addendum. Philips has revised the labeling in the addendum to specify the battery charge time with device turned off and AC power connected. The revised specification is: With temperature at 25C (77F), less than 3 hours to 100% capacity; less than 2 hours to 80% capacity. Please contact your local Philips Representative at 1-800-722-9377.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ IRELAND ISRAEL ITALY JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LITHUANIA MACAU MALAYSIA MALTA MAURITIUS MOROCCO MYANMAR (Burma) NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PALESTINE PERU PHILIPPINES POLAND PORTUGAL,QATAR ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SERBIA SEYCHELLES SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VIET NAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110825PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODESPhilips Medical Systems · 2012-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.