Device recall
Z-0073-2018: Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with…
FDA device recall · Class II · Northgate Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0073-2018 |
|---|---|
| Recall event | 77367 |
| Product | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically. |
| Product code | FFK |
| Recalling firm | Northgate Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2020 |
| 510(k) numbers | K914514 |
| FEI number | 1450997 |
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