Device Recall OArm Imaging system

  • Modelo / Serial
    Product Catalog Number: 9732719, 9733346, BI-700-00027-100, BI-70000027-120, BI-700-00027-230
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and India.
  • Descripción del producto
    O-Arm Imaging System || The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Navigation, Inc., 300 Foster St, Littleton MA 01460-2017
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source