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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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
Related recalls
Same manufacturer · Agfa N.V.
See all →- HighDR 800 Digital Radiography X-ray Table Front Lever Chain Potential Failure
FDA (Devices) · 2024-09-04
- HighMobile X-ray System Structural Cable Defect Affects Safety Function
FDA (Devices) · 2024-04-10
- HighAgfa DR 800 X-Ray System Recalled for Dose Calculation Error
FDA (Devices) · 2020-06-10
- HighAgfa DR 800 X-Ray System Recalled for Tomosynthesis Sequence Error
FDA (Devices) · 2020-03-25
- ModerateAgfa DR 800 Digital Radiography System Recalled for Image Mismatch
FDA (Devices) · 2019-08-07
Same hazard · image defect
See all →- ModerateNidek AFC-330 Fundus Camera Recalled for Image Defects
FDA (Devices) · 2014-07-09
Similar recalls
- LowAgfa Healthcare Recalls Radiographic Film Due to Fogged Sheets
FDA (Devices) · 2014-08-20
- LowAGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts
FDA (Devices) · 2014-12-24
- LowAgfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling
FDA (Devices) · 2013-03-27
- HighAbbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error
FDA (Devices) · 2019-12-18
- ModeratePolymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage
FDA (Devices) · 2018-09-26
- ModerateAGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction
FDA (Devices) · 2014-07-30