FDAFDA · Alimentos y medicamentos·N.º oficial Z-1264-2019
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Publicado el 8 de mayo de 2019 · Inicio del retiro: 20 de marzo de 2019
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
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
- Lote
- Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 190020NU01 87CX63006 030240NU11 87CX63015 705743NM870 87CX63011 M4184879 87CX63003 M9886873 87CX63004 X171582003 87CX63009 M171582018 87CX63010 UC1796NU01 87CX63013 NO1068MN18 87CX63005 A004NU20 87CX63002 C028NU01 87CX63012 C028NU02 87CX63001 900010NU12
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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