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Terminated

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

FDA Recall Z-0684-2007 · Posted 2007-03-30

Recalling FirmE.M.S. - Electro Medical Systems SA
Recall StatusTerminated
Product CodeFFK
Date Initiated2005-03-16
Date Terminated2016-02-02
Product Quantity160 units

Reason for Recall

Handpiece may become dislodged causing cable damage and possible electric shock.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012445EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)Electro Medical Systems SA · 2001-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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