FDAFDA · Alimentos y medicamentos·N.º oficial Z-0774-2014
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
Publicado el 5 de febrero de 2014 · Inicio del retiro: 20 de agosto de 2013
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
Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Carestream Health Inc.
- Distribuidor
- Nationwide Distribution including TX, IL, and GA.
- Lote
- Serial Numbers 5049, 5073, 5133, 5162
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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