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.
This recall has been terminated (originally issued January 25, 2019).
- Recall Initiated
- January 25, 2019
- Terminated
- June 14, 2019
- Recall Number
- Z-1034-2019
- Quantity
- 2029 boxes
- Official Source
- View on FDA website ↗
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
Distribution
US nationwide distribution in the state of OH.
Lot / Code Info
REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.
Root Cause
Mixed-up of materials/components
Action Taken
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.
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