Device recall
Z-1691-2019: Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital…
FDA device recall · Class II · NeuroLogica Corporation
Key facts
| Recall number (Z-number) | Z-1691-2019 |
|---|---|
| Recall event | 82862 |
| Product | Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications |
| Product code | IZL |
| Recalling firm | NeuroLogica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2020 |
| 510(k) numbers | K171119 |
| 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