AGFA Healthcare Corp. 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 Recall
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
AGFA Healthcare Corp.
Lot Codes / Batch Numbers
Lot 79440009
Products Sold
Lot 79440009
AGFA Healthcare Corp. is recalling Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4C due to Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026