Class III — Agfa N.V.
| Recalling firm | Agfa N.V. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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 frequencies and intensities |
| 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 frequencies and intensities. |
| Quantity | 2029 boxes |
| Distribution | US nationwide distribution in the state of OH. |
| Initiated | 2019-01-25 |
| Classified | 2019-03-21 |
| Terminated | 2019-06-14 |
| Recall number | Z-1034-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Agfa N.V. (Z-1034-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82123/
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