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Recall Observatory FDA recall evidence

Device product

Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

Z-1110-2014

February 04, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 67427
Status
Terminated
Classification
Class II
Quantity
58466 units
Official record key
device-enforcement:Z-1110-2014

Official wording

Reason: HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers

Code information: MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028

Distribution pattern: Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS¿ LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma)¿ NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers