Z-0078-04

LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss...

Name: Z-0078-04 LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss...
Creator: Electro Medical Systems (EMS SA)
Published: 2003-10-03
License: https://open.fda.gov/license/

E.M.S. - Electro Medical Systems SA / initiated 2003-10-03 / Terminated

FDA source

Electro Medical Systems (EMS SA) began a recall of LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700... on 2003-10-03. The reason FDA records is "Failure of foot pedal to activate device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0078-04
Status: Terminated
Initiated: 2003-10-03
Posted: 2003-10-31
Terminated: 2004-07-20
Recalling firm: E.M.S. - Electro Medical Systems SA
Product: LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Failure of foot pedal to activate device
FDA root cause: Other
Action: EMS notified US Distributor Boston Scientific by letter dated 10/3/03 advising them to to determine the client base and provide replacement foot pedals to the final user. Boston Scientific/Microvasive notified Hospital Risk Managers by letter dated 10/6/03.Sales representatives will visit accounts to replace the foot pedal.
Quantity in commerce: 96 units
Distribution: Nationwide Government: VA Hospitals:Decatur, GA;Biloxi, MS; Omaha,NB, Oklahoma CIty, OK;Muskogee, OK, West Palm Beach, FL Walter Reed Army Medical Center, Washington, DC
Product codes and lots: Units shipped prior to 3/03

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)