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U.S. Department of Health and Human Services

Class 2 Device Recall Boston/Scientifc

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  Class 2 Device Recall Boston/Scientifc see related information
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/
Electro Medical Systems (EMS SA)
Rte de Champ-Colin 2
Nyon Switzerland
For Additional Information Contact Robert Miragliuolo
Manufacturer Reason
for Recall
Failure of foot pedal to activate device
FDA Determined
Cause 2
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