medical Class III Updated 2019-03-27

Agfa N.V. recalls PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF:

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF CODE/ BATCH XJUB8 36930048; XJM73 36930048; XJUDD 36930047; XJUDD 36940001; XJM85 36940001; XJUDD 36940002; EKLYZ 36940003.
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