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U.S. Department of Health and Human Services

Class 2 Device Recall Philips HeartStart

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  Class 2 Device Recall Philips HeartStart see related information
Date Initiated by Firm June 05, 2015
Date Posted August 04, 2015
Recall Status1 Terminated 3 on February 25, 2019
Recall Number Z-2328-2015
Recall Event ID 71584
510(K)Number K110825  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product 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.
Code Information Serial Numbers in the following ranges: USO1100100 to USD1101095, US11201096 to USD1203968, US11303969 to USD1309471, US11409472 to US61414022
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 Multiple software and hardware issues with device that can affect its function.
FDA Determined
Cause 2		 Device Design
Action On June 29, 2015, Philips sent an Urgent Medical Device Correction notification/Field Safety Notice (FSN) to inform customers of the issue. The FSN identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. An upgrade consisting of both software and hardware will be provided free of charge for all units affected by these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Philips is asking customers to follow the "Action to be Taken by Customer/User" section of the Urgent Medical Device Correction notification/Field Safety Notice. For questions contact your local Philips representative.
Quantity in Commerce 13,168 devices
Distribution 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.
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
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