Device recall
Z-1040-2019: Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended…
FDA device recall · Class II · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-1040-2019 |
|---|---|
| Recall event | 82187 |
| Product | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)> |
| Product code | IZL |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2020 |
| 510(k) numbers | K080701 |
| FEI number | 1000513161 |
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