Device recall
Z-1250-2025: Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS…
FDA device recall · Class II · Medimaps Group
Key facts
| Recall number (Z-number) | Z-1250-2025 |
|---|---|
| Recall event | 96233 |
| Product | Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of… |
| Product code | KGI |
| Recalling firm | Medimaps Group |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152299 |
| FEI number | 3010208539 |
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