AGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts
AGFA Healthcare is recalling 142 units of Radiomat M+ NIF films because the coating may show small bright thin lines when processed.
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. The issue is a cosmetic artifact (bright thin line) rather than a safety hazard.
Plain-English summary
AGFA Healthcare Corp. is recalling 142 units of Radiomat M+ NIF films, including the 14 x 17, 35CM x 43CM, 10 x 12, and 25.4CM x 30.5CM sizes. The recall is limited to Lot 79440009.
The recall was initiated because some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. This issue may affect the quality of the processed film.
The affected products were distributed nationwide in the states of Alabama, Arizona, California, Louisiana, Michigan, Nebraska, New Hampshire, New Jersey, North Carolina, and Virginia. Consumers and healthcare facilities should stop using the affected film and contact AGFA Healthcare Corp. for instructions on return or replacement.
The recalled product
- Product
- Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
- Manufacturer
- AGFA Healthcare Corp.
- Hazard
- Affected units
- 142
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 (1)
- Lot 79440009
Distribution
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