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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStart XL Defibrillator/Monitor

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  Class 2 Device Recall Philips HeartStart XL Defibrillator/Monitor see related information
Date Initiated by Firm January 28, 2013
Date Posted February 21, 2013
Recall Status1 Open3, Classified
Recall Number Z-0871-2013
Recall Event ID 64201
510(K)Number K110825  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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
Code Information 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
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall
Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use
FDA Determined
Cause 2
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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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