FDAClass IIIDecember 24, 2014

Radiomat M+ NIF 14 x 17 recall

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

Why was Radiomat M+ NIF 14 x 17 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 79440009

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
Recalling firm
AGFA Healthcare Corp.
Quantity
142 units
Distribution
US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Recall date
December 24, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls