Recall of Device Recall Wireless footswitch.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sound Surgical Technologies, LLC.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Electrosurgical cutting & coagulation & accessories - Product Code GEI
  • Reason
    Failure to shut-off: surgical equipment, activated by a wireless foot switch with vaser system, may remain powered on when switch is no longer depressed.
  • Action
    Consignees were sent an Advisory Notice on 12/28/2007. The notification describes the defect. Sound Surgical will be contacting facilities to arrange a service call to install new cables between the footswitch receiver and the VASER system. Facilities may contact the Technical Service Center at 1-888-677-8765.


  • Model / Serial
    Model SP-9970214-005112010 and SP-9970214-005112232. All units.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution including USA states of AL, CA, CT, FL, GA, IN, KY, LA, MI, NJ, NY, OH, OK, PA, TX, and VA. Foreign Distribution to Colombia, Costa Rica and Switzerland.
  • Product Description
    Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232. Sound Surgical Technologies, LLC, Louisville, CO 80027.
  • Manufacturer


  • Manufacturer Address
    Sound Surgical Technologies, LLC, 357 Mccaslin Blvd Ste 100, Louisville CO 80027-2951
  • Manufacturer Parent Company (2017)
  • Source