Z-0684-2007

Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra...

Name: Z-0684-2007 Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra...
Creator: E.M.S. - Electro Medical Systems SA
Published: 2005-03-16
License: https://open.fda.gov/license/

E.M.S. - Electro Medical Systems SA / initiated 2005-03-16 / Terminated

FDA source

E.M.S. - Electro Medical Systems SA began a recall of Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System on 2005-03-16. The reason FDA records is "Handpiece may become dislodged causing cable damage and possible electric shock". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0684-2007
Status: Terminated
Initiated: 2005-03-16
Posted: 2007-03-30
Terminated: 2016-02-02
Recalling firm: E.M.S. - Electro Medical Systems SA
Product: Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Handpiece may become dislodged causing cable damage and possible electric shock.
FDA 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 in commerce: 160 units
Distribution: Nationwide
Product codes and lots: Units manufactured prior to January 2003

Product code FFK

K012445Class IIEms Swiss Lithoclast Master (A.k.a. Swiss Lithoclast Ultra)Electro Medical Systems SA / cleared 2001-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)