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
    74840
  • Event Risk Class
    Class 2
  • Event Number
    Z-2626-2016
  • Event Initiated Date
    2016-07-13
  • Event Date Posted
    2016-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148570
  • 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
    Due to an internal communication error between the firmware and the software of the components, the planned ct scan executes properly, but the injector is not started. therefore, the contrast agent is not injected and the desired examination result is not achieved. this error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.
  • Action
    Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions.

Device

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

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