Devices

Defibrillator

Fabricant

manufacturer #121
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA

1042 dispositifs médicaux avec un nom similaire

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Philips HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
    Devices manufactured prior to June 4, 2015. Affected serial numbers range from US00100100 - US00587045.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including Puerto Rico, and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, 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, Hungary, ICELAND, India, INDONESIA, ISLAMIC REPUBLIC OF IRAN, Iraq, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, 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, State of 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, UNITED REPUBLIC OF TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED, ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN
  • Description du dispositif
    Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. || For use for the termination of ventricular tachycardia and ventricular fibrillation.
  • Manufacturer
    Philips Electronics North America Corporation
Defibrillator / Pacer Analyzer
  • Modèle / numéro de série
    SN: 73962222, 73962223, 73962224, 73962225, and 73962226
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
  • Description du dispositif
    DA-2006P - Defibrillator / Pacer Analyzer; || Product Usage: || Intended to measure the output of a defibrillator or transcutaneous pacemaker.
  • Manufacturer
    BC Group International Inc
LifeVest Wearable Defibrillator
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide
  • Description du dispositif
    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. || The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
  • Manufacturer
    Zoll Manufacturing Corp.
Alto implantable cardioverter defibrillator
  • Modèle / numéro de série
    Model Numbers DR model 614, VR model 615
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
  • Description du dispositif
    Alto implantable cardioverter defibrillator
  • Manufacturer
    ela Medical Llc
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/moni...
  • Modèle / numéro de série
    Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Devices were distributed worldwide.
  • Description du dispositif
    QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
  • Manufacturer
    Medtronic Emergency Response Systems, Inc.
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