Agfa Radiographic Film Recalled for Visible Pinholes in Images
Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for cosmetic or documentation issues.
Plain-English summary
Agfa N.V. is recalling 2,029 boxes of PET Plates Coated Film-MONOMEDBV2S2 radiographic film. The affected product includes reference codes XJUB8, XJM73, XJUDD, XJM85, and EKLYZ, distributed in Ohio.
The recall is due to an inhomogeneous coating solution that can cause pinholes to become visible in even dark images. The visibility of these pinholes varies, with material from this coating run showing pinholes in different frequencies and intensities.
This recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected film and contact the manufacturer for further instructions.
The recalled product
- 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 show
- Manufacturer
- Agfa N.V.
- Hazard
- Affected units
- 2,029
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- REF CODE/ BATCH XJUB8 36930048
- XJM73 36930048
- XJUDD 36930047
- XJUDD 36940001
- XJM85 36940001
- XJUDD 36940002
- EKLYZ 36940003.
Distribution
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