Device recall
Z-1134-2026: Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1134-2026 |
|---|---|
| Recall event | 98215 |
| Product | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that… |
| Product code | EOQ |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212048 |
| FEI number | 3001675293 |
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