Device recall
Z-0333-2022: Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF…
FDA device recall · Class II · Northgate Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0333-2022 |
|---|---|
| Recall event | 88944 |
| Product | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi. |
| Product code | FFK |
| Recalling firm | Northgate Technologies, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130368 |
| 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