FDAFDA · Alimentos y medicamentos·N.º oficial Z-1424-2017
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Publicado el 15 de marzo de 2017 · Inicio del retiro: 20 de febrero de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA Inc.
- Distribuidor
- Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
- Lote
- 72444, 72470, 72476, 72480, 72487, 72494, 72515, 72526, 72545
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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