Device recall
Z-0055-05: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models…
FDA device recall · Class II · Fujifilm Medical System USA, Inc.
Key facts
| Recall number (Z-number) | Z-0055-05 |
|---|---|
| Recall event | 30206 |
| Product | Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 |
| Product code | MQB |
| Recalling firm | Fujifilm Medical System USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2004 |
| 510(k) numbers | K993861 |
| 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