Device recall
Z-2661-2023: Veran: Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2661-2023 |
|---|---|
| Recall event | 92893 |
| Product | Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029) |
| Product code | JAK |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093146, K122106, K170023 |
| FEI number | 2429304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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