FDA-Device2017-04-05Class I
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Philips North America, LLC
Hazard
HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Sold states
Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, CROATIA (local name: Hrvatska),CYPRUS,CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,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.
Affected count
97,794 total ( 47,362 US and 50,429 OUS)
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1417-2017Don't want to check this manually?
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