FDA Medical Device Recalls (openFDA)
E.M.S. - Electro Medical Systems SA: Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .
- Recall number
- Z-0684-2007
- 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 .
- Status
- Terminated
- Initiated
- 2005-03-16
- Posted
- 2007-03-30
- Terminated
- 2016-02-02
- 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
- Lot, serial or model codes
- Units manufactured prior to January 2003
- 510(k) numbers
- ["K012445"]
- PMA numbers
- not on file
- Product code
- FFK
- Firm FEI
- 3002806910
- Firm city
- Nyon
- Firm state
- Vaud
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28