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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0611-2025

GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system

Publicado el 11 de diciembre de 2024 · Inicio del retiro: 5 de noviembre 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

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare (China) Co., Ltd.
Distribuidor
Worldwide distribution.
Lote
UDI/DI 0019527856860, Serial/Sales Order Numbers: CBDOG2400029HM, CBDOG2400031HM, CBDOG2400030HM
Clasificación de riesgo
Class II
Área (FDA)
device
País
China

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