Z-1417-2017 Class I Terminated
FDA device recall Z-1417-2017 was initiated by Philips North America, LLC on February 24, 2017 and is designated Class I. Reason for recall: 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 The recall status is terminated (terminated April 17, 2020). Affected quantity: 97,794 total ( 47,362 US and 50,429 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- February 24, 2017
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97,794 total ( 47,362 US and 50,429 OUS)
Product Description
Reason for Recall
Distribution Pattern
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.