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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 30, 2009
Date Posted May 19, 2009
Recall Status1 Terminated 3 on September 04, 2012
Recall Number Z-1199-2009
Recall Event ID 51455
510(K)Number K021453  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart XL Model M4735A Defibrillator, Automatic, External
Defibrillator-Monitor.

The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Code Information Serial Numbers within the range of US00442485 through US00469873.   The following additional units are also affected because their energy select switches were replaced within the relevant time period: Serial Numbers:  US00100353 US00110688 US00121145 US00338153 US00100741 US00110914 US00121658 US00439208 US00100843 US00111399 US00123159 US00439504 US00101080 US00112143 US00124026 US00439652 US00101500 US00112685 US00125012 US00439661 US00102492 US00114680 US00125049 US00439688 US00102580 US00114900 US00125344 US00439930 US00102583 US00116677 US00126424 US00441252 US00102601 US00116965 US00127322 US00441758 US00102643 US00117003 US00127620 US00441855 US00103225 US00118060 US00213344 US00441862 US00103916 US00118260 US00213559 US00104178 US00118602 US00230434 US00105134 US00118915 US00230588 US00106329 US00118985 US00231849 US00106922 US00119444 US00232228 US00108281 US00119624 US00232394 US00108296 US00120241 US00233505 US00109777 US00120466 US00234442 US00110403 US00120589 and US00234615.
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent - Medical Device Recall Letter and Notice dated March 2009 were issued to affected customers. Mailings of the Urgent - Medical Device Recall Letter and Notice were handled by Philips Healthcare representatives in each affected geography. Customers were asked to follow the "Actions to be taken by customer/user" section of the Urgent - Medical Device Recall Notice. In this section, customers were instructed to remove the device from service if possible, while they await the correction of their device. If the customer is unable to remove the device from service, they are asked to identify a readily available backup device to use in the event that their device becomes unusable. All customers will be contacted by a Philips Healthcare representative to arrange for replacement of the energy select switch in the affected devices (Mandatory Field Change Order FCO86100076). Contact your local Philips Healthcare representative for additional information or support concerning this issue.
Quantity in Commerce 26,992
Distribution Worldwide Distribution -- UNITED STATES, CANADA, ALBANIA, ARGENTINA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY,GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN,KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACAU, MACEDONIA, MALAYSIA,MALI, MARTINIQUE, MAURITIUS, MEXICO, MONGOLIA, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PALESTINE, PANAMA, PARAGUAY, PERU,PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO,ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA,THAILAND, TRINIDAD AND TOBAGO, TURKEY,TUNESIA, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, VIRGIN ISLANDS and YEMEN.
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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