LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/
FDA device recall Z-0078-04 · posted 2003-10-31 · Terminated
Recall details
- Recalling firm
- Electro Medical Systems (EMS SA)
- Reason for recall
- Failure of foot pedal to activate device
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 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
- Date initiated
- 2003-10-03
- Date posted
- 2003-10-31
- Date terminated
- 2004-07-20
- Location
- Nyon, Switzerland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (K012445) | Electro Medical Systems SA | 2001-08-24 |