Device Recall AMO WaveScan WaveFront System v3.65

  • Modelo / Serial
    All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
  • Descripción del producto
    Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    VISX INCORPORATED, A SUBSIDIARY OF AMO INC, 3400 Central Expy, Santa Clara CA 95051-0703
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA