FDAFDA · Alimentos y medicamentos·N.º oficial Z-0552-2025
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
Publicado el 4 de diciembre de 2024 · Inicio del retiro: 1 de octubre 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
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Abbott Medical
- Distribuidor
- Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.
- Lote
- Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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