PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8 — Class III medical device recall Z-1034-2019
Terminated recall by Agfa N.V., reported 2019-03-27, distributed nationwide. Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the p
| Recall number | Z-1034-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, N/A, Belgium |
| Recall initiated | 2019-01-25 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2019-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,029 boxes |
| Lot numbers | 36930048, XJM73, XJUB8 |
| Model numbers | XJM73, XJUB8 |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1034-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.