Events

Recall of Device Recall 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
    75677
  • Event Risk Class
    Class 2
  • Event Number
    Z-0607-2017
  • Event Initiated Date
    2016-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151033
  • 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
    Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with somatom definition as, somatom definition edge, somatom definition flash systems with software version va48a_sp2 and care contrast license correction of potential safety issues.
  • Action
    Siemens mailed a Customer Safety Notice on November 9, 2016, to customers who were affected by the recall to inform them of a possible malfunction with the systems. The notification explained the underlying issue, the effect if has on the operation of the system, potential risks involved; and the actions they plan to implement to correct the issues. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6471.

Device

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

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