Events

Recall of Device Recall SOMATOM Definition AS

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
    73639
  • Event Risk Class
    Class 2
  • Event Number
    Z-1350-2016
  • Event Initiated Date
    2016-03-22
  • Event Date Posted
    2016-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144645
  • 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 became aware that the front cover on some siemens ct system was not properly welded. it is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. this could not happen during clinical operation. therefore, there is no potential risk for the user or patient and the ct system has no risk for a malfunction during clinical operation.
  • Action
    Siemens sent an "Informational Only" notice to customers on 03/22/2016 informing them to be aware that the front cover on some Siemens CT systems was not properly welded. The letter was only to notify customers that the issue is being addressed with the completion of a service visit. In addition, Siemen plans to replace each cover and hand delivered each notification to customers at the time the service is performed.

Device

Device Recall SOMATOM Definition AS
  • Model / Serial
    Model Number: SOMATOM Definition AS-8098027 Serial # SOMATOM Definition AS- 95766
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: Cincinnati, OH.
  • Product Description
    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta 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