Events

Recall of 3DI/III Ceiling Stand

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
    35395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1205-06
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2006-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45995
  • 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
    Tube Mount, X-Ray, Diagnostic - Product Code IYB
  • Reason
    Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. risk of injury to operators fingers.
  • Action
    The recalling firm has issued a field correction per Update Instructions AX012/06/S. This update instructs a Siemens Customer Service Engineer to visit affected consignees to install a protective cover and additional warning labels on the device, beginning 04/28/2006.

Device

3DI/III Ceiling Stand
  • Model / Serial
    Model numbers 0923/G0923, 1022, 1080, 1212687, 1371970, 1372325, 1654250, 1576164, 8186751, 7388002, 7389489, 1738509, 1738517, 1738525, 7276504, 7276512, 7276520, 7276553, 7465008, 7486822, and 8185530.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were shipped nationwide to medical facilities.
  • Product Description
    3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA