Device recall
Z-1642-2014: MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM…
FDA device recall · Class II · Fujifilm Medical System USA, Inc.
Key facts
| Recall number (Z-number) | Z-1642-2014 |
|---|---|
| Recall event | 67958 |
| Product | MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator |
| Product code | MUE |
| Recalling firm | Fujifilm Medical System USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2018 |
| FEI number | 1000513161 |
At a glance
- None 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