Agfa N.V. recalls PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an…

Recall date

January 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1034-2019

FDA classification

Class III

Brand / firm

Agfa N.V.

Sold / distributed

US nationwide distribution in the state of OH.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.