FDA Medical Device Recalls (openFDA)
Agfa N.V.: 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.
- Recall number
- Z-1034-2019
- Recalling firm
- Agfa N.V.
- 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.
- Status
- Terminated
- Initiated
- 2019-01-25
- Posted
- not on file
- Terminated
- 2019-06-14
- 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
- Root cause
- Mixed-up of materials/components
- Action
- Agfa issued Medical Device Recall letter by email dated 1/28/19 stating the problem, action to be taken, health risk and to block the material to prevent distribution.
- Quantity
- 2029 boxes
- Distribution
- US nationwide distribution in the state of OH.
- Lot, serial or model codes
- REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWZ
- Firm FEI
- 3001556265
- Firm city
- Mortsel
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28