FDA-Device2019-03-27Class III
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.
Agfa N.V.
Hazard
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
Sold states
US nationwide distribution in the state of OH.
Affected count
2029 boxes
Manufactured in
Septestraat 27, N/A, Mortsel, N/A, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1034-2019Don't want to check this manually?
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