FDAFDA · Alimentos y medicamentos·N.º oficial Z-1921-2024
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Publicado el 19 de junio de 2024 · Inicio del retiro: 8 de mayo de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Thoratec Corp.
- Distribuidor
- Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GUADELOUPE, GREECE, IRELAND, ISRAEL, IRAN, ISLAMIC REPUBLIC OF, ITALY, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MARTINIQUE, NETHERLANDS, NORWAY, OMAN, POLAND, PALESTINE, PORTUGAL, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SWEDEN, SLOVENIA, TUNISIA, TURKEY, SOUTH AFRICA, CANADA, AUSTRALIA, HONG KONG, MALAYSIA, SINGAPORE, SOUTH KOREA, TAIWAN, THAILAND, JAPAN, BANGLADESH, INDIA, PAKISTAN, ARGENTINA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, MEXICO, and BRAZIL
- Lote
- UDI-DI: 00813024010142, 00813024010852. All Serial Numbers
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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