Device recall
Z-0263-2016: Samsung GM60A-40S Intended for use in generating radiographic images of human…
FDA device recall · Class II · NeuroLogica Corporation
Key facts
| Recall number (Z-number) | Z-0263-2016 |
|---|---|
| Recall event | 72171 |
| Product | Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy. |
| Product code | IZI |
| Recalling firm | NeuroLogica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2017 |
| 510(k) numbers | K142492, K150097 |
| FEI number | 3004938766 |
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