Events

Recall of Device Recall Sonesta 6303

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
    53817
  • Event Risk Class
    Class 2
  • Event Number
    Z-0566-2010
  • Event Initiated Date
    2009-11-03
  • Event Date Posted
    2009-12-23
  • 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=86580
  • 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
    Electric Cystometric Table - Product Code MMZ
  • Reason
    There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
  • Action
    Stille sent Field Safety Notices dated 10/30/09 to the direct accounts, informing them that there is a potential hazard with the Sonesta tables if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. Stille developed a retrofit kit consisting of six side rail bolts and instructions for installing the bolts, which were sent to the end users with the safety notice. The accounts were requested to replace the side rail bolts with the new bolts provided, and to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 12/11/09. Contact Stille Surgical Inc. at 224-612-5404 for assistance.

Device

Device Recall Sonesta 6303
  • Model / Serial
    Model 6303, serial numbers 12-11076, 12-11077, 12-11078, 12-11079, 12-11080, 12-11081, 12-11082, 12-11083, 12-11084, 12-11086, 12-11127, 12-11129, 12-11133, 12-11134, 12-11137, 12-11141, 12-11145, 12-11273, 12-11274; tables sold between 3/24/09 and 9/30/09
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Including countries of USA and Canada.
  • Product Description
    Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden. || Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures.
  • Manufacturer
    Stille AB

Manufacturer

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