FDAFDA · Alimentos y medicamentos·N.º oficial Z-0226-2016
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Publicado el 11 de noviembre de 2015 · Inicio del retiro: 28 de septiembre de 2015
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
Inaccurate distance measurements with magnified projection X-ray images.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare
- Distribuidor
- Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.
- Lote
- 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States