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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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  Class 2 Device Recall Philips Healthcare see related information
Date Initiated by Firm March 31, 2014
Date Posted April 09, 2014
Recall Status1 Terminated 3 on October 21, 2015
Recall Number Z-1439-2014
Recall Event ID 67857
510(K)Number K110825  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290, automatic external defibrillator.
Code Information Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269 
Recalling Firm/
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS