Devices

Device Recall SOMATOM Definition Edge

  • Model / Serial
    Model Number: 10590000 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Product Description
    Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
  • 1 Event

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall SOMATOM Definition Edge
  • Model / Serial
    Model # 8098027  Serial # 96020, 96047, 96011, and 96029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: MI, NY, CA, KY, ND, NE
  • Product Description
    SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall SOMATOM Definition Edge
  • Model / Serial
    Model Number: 1059000 Serial Numbers:96020, 96047,74192,83398,96011,83387 96029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MI, NY, CA, KY, ND, and NE.
  • Product Description
    SOMATOM Definition Edge, Computed tomography x-ray system || The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended 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
    Siemens Medical Solutions USA, Inc
Device Recall SOMATOM Definition edge
  • Model / Serial
    Serial Numbers:83249 83277 83632 83336 83401 83204 83562 83564 83582 83390 83088 83234 83235 83645 83321 83527 83332 83026 83281 83558 83546 83339 83244 83585 83613 83226 83330 83214 83271 83607 83403 83599 83246 83388 83021 83584 83591 83574 83210 83552 83541 83020 83626 83308 83375 83227 83359 83031 83520 83262 83557 83081 83292 83090 83544 83083 83096 83294 83319 83581 83056 83041 83363 83307 83236 83348 83567 83378 83399 83258 83084 83004 83237 83205 83014 83573 83233 83352 83569 83537 83355 83395 83621 83335 83278 83322 83392 83622 83276 83279 83327 83091 83371 83533 83597 83034 83059 83230 83254 83267 83055 83291 83046 83524 83044 83243 83637 83640 83232 83362 83306 83542 83257 83539 83094 83239 83398 83565 83313 83653 83347 83349 83323 83324 83618 83266 83387 83516 83627 83095 83042 83611 83633 83589
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
  • Product Description
    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
  • Manufacturer
    Siemens Medical Solutions USA, Inc