Device recall
Z-2178-2014: Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355…
FDA device recall · Class III · AGFA Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-2178-2014 |
|---|---|
| Recall event | 68844 |
| Product | Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of… |
| Product code | IWZ |
| Recalling firm | AGFA Healthcare Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 9, 2014 |
| 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