Class 2 Device Recall EMS Lithocast Ultra Ultrasound Handpiece

• Date Initiated by Firm: March 16, 2005
• Date Posted: March 30, 2007
• Recall Status: Terminated 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
• FEI Number: 3002806910
• 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: 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