Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets
Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.
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. The issue is a quality defect (fogging) rather than a direct safety hazard like injury or death.
Plain-English summary
Agfa Healthcare Corp. is recalling 2,617 units of various radiographic film products, including Radiomat M+ NIF, Radiomat SG 14 x 17 NIF, and CX Ultra UV-G Plus NIF. The recall affects specific lot numbers: 79350052, 79380052, 79390074, 79400066, and 79410063.
The recall was initiated because some sheets of the medical screen film are fogged. Radiographic film is a device used to record images during diagnostic radiologic procedures. The fogging may impact the quality of the recorded images.
The affected products were distributed worldwide and in the United States in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC, and in Canada. Users should check their inventory for the listed lot numbers and stop using the affected film.
The recalled product
- Product
- Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists
- Manufacturer
- AGFA Healthcare Corp.
- Hazard
- Affected units
- 2,617
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 (5)
- Lot Batch No. 79350052
- 79380052
- 79390074
- 79400066
- 79410063
Distribution
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