Device Recall Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license

  • Modèle / numéro de série
    Material 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470 10762470  serial numbers24077 24051 24038 24059 24066 24015 24026 24058 24039 24090 24075
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
  • Description du dispositif
    Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. || The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Société-mère du fabricant (2017)
  • Source
    USFDA