Events

Recall of Device Recall EMS Lithocast Ultra Ultrasound Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by E.M.S. - Electro Medical Systems SA.

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
    37168
  • Event Risk Class
    Class 2
  • Event Number
    Z-0684-2007
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2007-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50032
  • 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
    Lithotripter handpiece - Product Code FFK
  • Reason
    Handpiece may become dislodged causing cable damage and possible electric shock.
  • Action
    EMS Lyon, France (manufacturer) notified the single US Distributor by letter to contact their accounts and return device for replacement. Boston Scientific, Natick, Ma conducted the sub-recall by letter dated 4/22/05 to all USA accounts.

Device

Device Recall EMS Lithocast Ultra Ultrasound Handpiece
  • Model / Serial
    Units manufactured prior to January 2003
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
  • Manufacturer
    E.M.S. - Electro Medical Systems SA

Manufacturer

E.M.S. - Electro Medical Systems SA
  • Manufacturer Address
    E.M.S. - Electro Medical Systems SA, Chemin de la Vuarpilliere 31, Nyon, Vaud Switzerland
  • Source
    USFDA