Device Recall Siemens Emotion 16, Emotion 6, and Spirit Computed Tomography Systems

  • Modèle / numéro de série
    Material numbers: 10165977, 10045692 , and 10165888 with serial numbers: 32187 31158 31215 31222 31313 31354 32118 32120 32123 32125 32126 32127 32129 32139 29161 27229 29185 27415 27212 29364 29186 29165 29233 29182 27235 29338 29176 29376 27232 29181 27369 29295 27230 29198 27244 29286 29126 27338 29302 27231 27334 29394 29264  32141 32156 32159
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of IA, TX, FL, NE, NY, OH, NC, KS, IL, CA, OK including PR.
  • Description du dispositif
    Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems || Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • Manufacturer
  • 1 Event

Fabricant

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