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U.S. Department of Health and Human Services

Class 2 Device Recall EMS Lithocast Ultra Ultrasound Handpiece

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  Class 2 Device Recall EMS Lithocast Ultra Ultrasound Handpiece see related information
Date Initiated by Firm March 16, 2005
Date Posted March 30, 2007
Recall Status1 Terminated 3 on February 02, 2016
Recall Number Z-0684-2007
Recall Event ID 37168
510(K)Number K012445  
Product Classification Lithotripter handpiece - Product Code FFK
Product Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
Code Information Units manufactured prior to January 2003
Recalling Firm/
Manufacturer		 E.M.S. - Electro Medical Systems SA
Chemin de la Vuarpilliere 31
Nyon, Vaud Switzerland
For Additional Information Contact Robert Miragliuolo
508-683-4900
Manufacturer Reason
for Recall		 Handpiece may become dislodged causing cable damage and possible electric shock.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 160 units
Distribution Nationwide
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
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