Events

Recall of Device Recall Stille Sonesta Video Fluoroscopy Table 6210

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stille-Sonesta, 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
    36855
  • Event Risk Class
    Class 2
  • Event Number
    Z-0504-2007
  • Event Initiated Date
    2006-11-09
  • Event Date Posted
    2007-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49460
  • 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
    Fluoroscopy Table - Product Code IXR
  • Reason
    Bolts may back out of their joints causing the back section of the table to tilt.
  • Action
    Notifications letters sent to consignees on 11/20/06. Users are instructed to check the bolts located under the table. The Notice includes instructions with pictures for checking the bolts and tightening them if necessary. Stille AB has developed a kit for replacing the bolt that is involved and will send a service engineer out to the site to do the replacement.

Device

Device Recall Stille Sonesta Video Fluoroscopy Table 6210
  • Model / Serial
    Serial Numbers:  12-70000 - 12-70017, 00010, 00012, 00013 - 00022, 00024 - 00027, 00030 - 00034, 00036 - 00040, 00043 - 00044, 00045 - 00049, 00053 - 00054, 00057 - 00065, 00067 - 00069, 00071.  Outside U.S. Serial Numbers: 12-70018 - 12-70019, 23-70000 - 23-70009, 23-70008, 23-700010, 00011, 00023, 00028 - 00029, 00050 - 00052, 00055 - 00056, 00066, 00072, 00073, 00074.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.
  • Manufacturer
    Stille-Sonesta, Inc

Manufacturer

Stille-Sonesta, Inc
  • Manufacturer Address
    Stille-Sonesta, Inc, 2220 Canton St Apt 209, Dallas TX 75201-5932
  • Source
    USFDA