Device recall
Z-1034-2019: PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD…
FDA device recall · Class III · Agfa N.V.
Key facts
| Recall number (Z-number) | Z-1034-2019 |
|---|---|
| Recall event | 82123 |
| Product | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different… |
| Product code | IWZ |
| Recalling firm | Agfa N.V. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 14, 2019 |
| FEI number | 3001556265 |
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