FDA-Device2014-12-24Class III

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

AGFA Healthcare Corp.
Hazard

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Sold states
US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Affected count
142 units
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2015

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