St Jude Medical CRMD

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Description

44 dispositivos en la base de datos

  • Modelo / Serial
    All Devices (all serial numbers for the devices referenced in the advisory.)
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA
  • Descripción del producto
    St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
  • Modelo / Serial
    All Devices (all serial numbers for the devices referenced in the advisory.)
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA
  • Descripción del producto
    St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
  • Modelo / Serial
    All Devices (all serial numbers for the devices referenced in the advisory.)
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA
  • Descripción del producto
    St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
  • Modelo / Serial
    Models PM3110, 3112, 3210,3212 (Anthem) and    All lots and serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
  • Descripción del producto
    Anthem CRT-P models PM3110 and PM3210 || St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
  • Modelo / Serial
    PM2110, 2112, 2210, 2212 (Accent DR)  All lots and serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.
  • Descripción del producto
    Implantable Pacemaker Accent DR models PM2110 and PM2210 || St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
    SMPA