Device Recall Siemens Medical Somatom Computed Tomography System

  • Model / Serial
    Somatom Sensation 4 -- Serial Numbers 28001 to 28070 Somatom Volume Zoom -- Serial Numbers 24006 to 24752 Somatom Volume Access -- Serial Numbers 26111 to 26123 Somatom Valance -- Serial Numbers 38169 to 38475 Somatom Emotion -- Serial Numbers 40354 to 40383 Somatom Emotion Duo -- Serial Numbers 36081 to 36126 Somatom Esprit -- Serial Numbers 34191 to 34213 Somatom Esprit+ -- Serial Numbers 35024 to 35039
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
  • Product Description
    Computed Tomography system, Diagnostic Imaging: || Somatom Sensation 4 || Somatom Volume Zoom || Somatom Volume Access || Somatom Balance || Somatom Emotion || Somatom Emotion Duo || Somatom Esprit || Somatom Esprit +
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Systems Inc, 186 Wood Ave So, Iselin NJ 08830
  • Source
    USFDA