Device recall
Z-0369-2017: TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device…
FDA device recall · Class II · Medimaps Group
Key facts
| Recall number (Z-number) | Z-0369-2017 |
|---|---|
| Recall event | 75510 |
| Product | TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management. |
| Product code | KGI |
| Recalling firm | Medimaps Group |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2017 |
| 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