FDAFDA · Alimentos y medicamentos·N.º oficial Z-1693-2019
IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.
Publicado el 12 de junio de 2019 · Inicio del retiro: 28 de marzo de 2019
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
The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips North America, LLC
- Distribuidor
- Worldwide distribution - US Nationwide and to 71 countries.
- Lote
- All revision B.X versions are affected.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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