Recall Z-0804-2015— AGFA Healthcare Corp.

Name: FDA recall Z-0804-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-24

Class III · Terminated

Class III FDA medical device recall by AGFA Healthcare Corp., initiated 2014-10-24, terminated 2015-03-16. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed..

Recalling firm: AGFA Healthcare Corp.
Classification: Class III
Status: Terminated
Initiated: 2014-10-24
Terminated: 2015-03-16
Firm location: Greenville, SC, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.