FDAFDA · Alimentos y medicamentos·N.º oficial Z-0475-2013
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Publicado el 12 de diciembre de 2012 · Inicio del retiro: 30 de octubre de 2012
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
With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Healthcare Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Libya, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
- Lote
- All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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