CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report

Philips HeartStart XL+ Defibrillator/Monitor recalled

Philips Electronics North America is recalling Philips HeartStart XL+ Defibrillator/Monitor, distributed nationwide in the US. The recall was initiated on 5 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers in the following ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022

Quantity recalled13,168 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2328-2015
FDA event ID: 71584
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2015
FDA classified: 4 Aug 2015
Reported: 12 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

5 Jun 2015	Recall initiated by company
4 Aug 2015	Classified by FDA	+60 days
12 Aug 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial Numbers in the following ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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