Events

Recall of Device Recall Siemens SOMATOM Definition Edge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75812
  • Event Risk Class
    Class 2
  • Event Number
    Z-0744-2017
  • Event Initiated Date
    2016-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151560
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    Software update that provides software and firmware bug-fixes to improve system performance.
  • Action
    Siemens mailed a Customer Information Letter to affected customers on November 21, 2016 informing them of software updates that would provide bug-fixes to improve system performance and stability for customers with SOMATOM Definition AS, Definition Edge and Definition Flash systems using Software versions VA48A_SP1 and VA48A_SP2. The update will remotely be pushed to their systems or customers will be contacted by one of Siemens service organization to arrange a date for installation of the update on site. Customers with questions were instructed to call 1-800-888-7436.

Device

Device Recall Siemens SOMATOM Definition Edge
  • Model / Serial
    Model # 10590000 Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SOMATOM Definition Edge System, x-ray, tomography, computed || 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

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