FDAFDA · Alimentos y medicamentos·N.º oficial Z-1187-2017
BrightView X upgraded to XCT 882454
Publicado el 22 de febrero de 2017 · Inicio del retiro: 23 de diciembre de 2016
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
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems (Cleveland) Inc
- Distribuidor
- Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
- Lote
- Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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