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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FFK
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