FDAFDA · Alimentos y medicamentos·N.º oficial Z-2267-2014
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
Publicado el 27 de agosto de 2014 · Inicio del retiro: 3 de julio de 2014
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
In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Intelerad Medical Systems
- Distribuidor
- Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
- Lote
- software versions 3-8-1 to 4-9-1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Canada
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.