Events

Recall of Boston/Scientifc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Electro Medical Systems (EMS 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
    27447
  • Event Risk Class
    Class 2
  • Event Number
    Z-0078-04
  • Event Initiated Date
    2003-10-03
  • Event Date Posted
    2003-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29894
  • 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
    Lithotriptor, Electro-Hydraulic - Product Code FFK
  • Reason
    Failure of foot pedal to activate device.
  • Action
    EMS notified US Distributor Boston Scientific by letter dated 10/3/03 advising them to to determine the client base and provide replacement foot pedals to the final user. Boston Scientific/Microvasive notified Hospital Risk Managers by letter dated 10/6/03.Sales representatives will visit accounts to replace the foot pedal.

Device

Boston/Scientifc
  • Model / Serial
    Units shipped prior to 3/03
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Government: VA Hospitals:Decatur, GA;Biloxi, MS; Omaha,NB, Oklahoma CIty, OK;Muskogee, OK, West Palm Beach, FL Walter Reed Army Medical Center, Washington, DC
  • Product Description
    LithoClast Foot Pedal, reference EK-166 || Catalog Number: 840-703 || Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA
  • Manufacturer
    Electro Medical Systems (EMS SA)

Manufacturer

Electro Medical Systems (EMS SA)
  • Manufacturer Address
    Electro Medical Systems (EMS SA), Rte de Champ-Colin 2, Nyon Switzerland
  • Source
    USFDA