—#138263

Product

Philips HeartStart XL+ Defibrillator/Monitor Product Usage: 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 product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K110825
Affected lot / code info: Serial Numbers in the following ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022

Why it was recalled

Multiple software and hardware issues with device that can affect its function.

Root cause (FDA determination)

Device Design

Action the firm took

On June 29, 2015, Philips sent an Urgent Medical Device Correction notification/Field Safety Notice (FSN) to inform customers of the issue. The FSN identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. An upgrade consisting of both software and hardware will be provided free of charge for all units affected by these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Philips is asking customers to follow the "Action to be Taken by Customer/User" section of the Urgent Medical Device Correction notification/Field Safety Notice. For questions contact your local Philips representative.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide including PUERTO RICO, Canada, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICA, 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, JAPAN, Jordan, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBERIA, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SEYCHELLES, SINGAPORE, SLOVAKIA (Slovak Republic), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, United Republic of TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM and ZIMBABWE.

Timeline

Recall initiated: 2015-06-05
Posted by FDA: 2015-08-04
Terminated: 2019-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.