Recall Z-0078-04 ยท FFK Lithotriptor, Electro-Hydraulic
Electro Medical Systems (EMS SA)
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
| Date | Oct 31, 2003 (initiated Oct 3, 2003) |
| Status | Terminated |
| Reason | Failure of foot pedal to activate device |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA, Aug 24, 2001 |