Terminated

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.

FDA Recall Z-1199-2009 · Posted 2009-05-19

Recalling FirmPhilips Healthcare Inc.

Recall StatusTerminated

Product CodeMKJ

Date Initiated2009-03-30

Date Terminated2012-09-04

Product Quantity26,992

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021453HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735APhilips Medical Systems · 2002-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.