FDA Device recall Z-1034-2019
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coati…
- FDA Device
- Class III
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class III recall of PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coati… by Agfa N V, citing 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 di….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1034-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-25 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Agfa N V |
| Distribution | US |
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
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
Identifiers
| code_info | REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001;…REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2019%22
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