Device recall
Z-0078-04: LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an…
FDA device recall · Class II · Electro Medical Systems (EMS SA)
Key facts
| Recall number (Z-number) | Z-0078-04 |
|---|---|
| Recall event | 27447 |
| 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 |
| Recalling firm | Electro Medical Systems (EMS SA) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2004 |
| 510(k) numbers | K012445 |
| FEI number | 3004096429 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database