Z-0871-2013Class II

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a...

Name: Z-0871-2013 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a...
Creator: Philips Healthcare Inc.
Published: 2013-01-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-01-28 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel... on 2013-01-28. FDA classified it as Class II and gives the reason as "Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0871-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-28
Posted: 2013-02-21
Terminated: 2020-09-03
Recalling firm: Philips North America LLC
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
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent Medical Device Recall letter dated January 2013 on January 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if the Philips HeartStart XL+ Defibrillator/Monitor is first powered on and then there is disconnection or an interruption in AC power, the device may be locked out of clinical mode until the user enters the service mode password and performs an Operational Check. Users are provided with the Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Customers were advised to follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a software upgrade to customers with affected units free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in commerce: 3785 units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0871-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0871-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-21

Product code MKJ

K110825Class IIIPhilips Heartstart Xl+, Philips Heartstart External Paddles, Philips Multifunction ElectrodesPhilips Medical Systems / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)