Events

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
    Recall
  • Event ID
    46293
  • Event Risk Class
    Class 2
  • Event Number
    Z-0933-2008
  • Event Initiated Date
    2007-12-28
  • Event Date Posted
    2008-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67151
  • 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.

Device

Device Recall Wireless footswitch.
  • Model / Serial
    Model SP-9970214-005112010 and SP-9970214-005112232. All units.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
    Sound Surgical Technologies, LLC

Manufacturer

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