Events

Recall of 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
    72091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0019-2016
  • Event Initiated Date
    2015-08-14
  • Event Date Posted
    2015-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139817
  • 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 bug issues for sw-version va48a_sp0. the following safety issues were resolved: 1) correction to improve visual warning and error indication son the gantry display. 2) correction to improve acquisition data in order to optimize image quality. 3) correction to improve robustness and general system behavior in some exception handling procedures. 4) correction to improve auto post processin.
  • Action
    A customer advisory notice, dated 8/14/15, was sent to direct accounts advising them of the issue to observe the safety notice and comply with the corresponding measure until the update has been fully completed.

Device

SOMATOM Definition Edge
  • Model / Serial
    Model#' 10590000 with Serial numbers 83277 83281 83021 83004 83014 83276 83279
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    SOMATOM Definition Edge; 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