Recall Z-0684-2007 ยท FFK Lithotriptor, Electro-Hydraulic
E.M.S. - Electro Medical Systems SA
Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
| Date | Mar 30, 2007 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | Handpiece may become dislodged causing cable damage and possible electric shock. |
| Root 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 | 160 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA, Aug 24, 2001 |