Z-1439-2014Class II

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator

Name: Z-1439-2014 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator
Creator: Philips Medical Systems, Inc.
Published: 2014-03-31
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-31 / Terminated

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator on 2014-03-31. FDA classified it as Class II and gives the reason as "A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1439-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Posted: 2014-04-09
Terminated: 2015-10-21
Recalling firm: Philips North America LLC
Product: Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
FDA root cause: Reprocessing Controls
Action: Philips Healthcare issued an Urgent-Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy. Please see the attached Field Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Please follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a replacement therapy board to customers with affected units free of charge. This voluntary correction has been reported to the appropriate regulatory agencies. If you need any further information or support concerning this issue, please contact your local Philips representative at Philips representative contact details to be completed by the KM / country. Philips apologizes for any inconveniences caused by this problem. Further questions please call (978) 687-1501.
Quantity in commerce: 19 units
Distribution: Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
Product codes and lots: Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1439-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1439-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)