Events

Recall of Device Recall Sonesta 6210 Fluoroscopy Procedure Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stille AB.

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
    49407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0119-2009
  • Event Initiated Date
    2008-08-27
  • Event Date Posted
    2008-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73269
  • 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
    Radiographic Table - Product Code IXR
  • Reason
    The table contains a battery backup, not mentioned in the user manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. however, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w.
  • Action
    Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.

Device

Device Recall Sonesta 6210 Fluoroscopy Procedure Table
  • Model / Serial
    Model 6210, all serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden
  • Manufacturer
    Stille AB

Manufacturer

Stille AB
  • Manufacturer Address
    Stille AB, Gardsvagen 14, Solna Sweden
  • Manufacturer Parent Company (2017)
    Linc AB
  • Source
    USFDA