Events

Recall of Device Recall Linemaster 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
    57630
  • Event Risk Class
    Class 2
  • Event Number
    Z-0939-2011
  • Event Initiated Date
    2010-12-21
  • Event Date Posted
    2011-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96889
  • 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 and Coagulation Device and Accessories - Product Code GEI
  • Reason
    Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.
  • Action
    Customers were notified by e-mail with an Advisory Notice on 12/21/2010. The Notice identified the affected product and described the issue. The Notice also explained what the potential hazard involved along with a mechanism to eliminate the potential hazard. Sound Surgical would arrange a service call to implement the correction at the firm's expense. If customers experience this potential failure, they are to contact Sound Surgical Technologies at 1-888-677-8765 or 1-888-471-4777.

Device

Device Recall Linemaster Wireless Footswitch
  • Model / Serial
    Serial numbers VNT10-0102 thru VNT10-0128.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, MA, MI, MO, NJ, NY, PA, and TX .
  • Product Description
    Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies LLC, 357 South McCaslin Blvd., Suite 100, 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