Date Initiated by Firm |
October 03, 2003 |
Date Posted |
October 31, 2003 |
Recall Status1 |
Terminated 3 on July 20, 2004 |
Recall Number |
Z-0078-04 |
Recall Event ID |
27447 |
510(K)Number |
K012445
|
Product Classification |
Lithotriptor, Electro-Hydraulic - Product Code FFK
|
Product |
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 |
Code Information |
Units shipped prior to 3/03 |
Recalling Firm/ Manufacturer |
Electro Medical Systems (EMS SA) Rte de Champ-Colin 2 Nyon Switzerland
|
For Additional Information Contact |
Robert Miragliuolo 508-650-8156
|
Manufacturer Reason for Recall |
Failure of foot pedal to activate device
|
FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
96 units |
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 |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FFK and Original Applicant = ELECTRO MEDICAL SYSTEMS SA
|