Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
FDA device recall Z-0684-2007 · posted 2007-03-30 · Terminated
Recall details
- Recalling firm
- E.M.S. - Electro Medical Systems SA
- Reason for recall
- Handpiece may become dislodged causing cable damage and possible electric shock.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 160 units
- Distribution
- Nationwide
- Date initiated
- 2005-03-16
- Date posted
- 2007-03-30
- Date terminated
- 2016-02-02
- Location
- Nyon, Vaud, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445) | Electro Medical Systems SA | 2001-08-24 |