Device recall
Z-0285-2012: Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to…
FDA device recall · Class III · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-0285-2012 |
|---|---|
| Recall event | 60166 |
| Product | Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information. |
| Product code | IWZ |
| Recalling firm | AGFA Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 22, 2011 |
| FEI number | 3001236302 |
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