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Terminated

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

FDA Recall Z-0804-2015 · Posted 2014-12-16

Recalling FirmAGFA Healthcare Corp.
Recall StatusTerminated
Product CodeIWZ
Date Initiated2014-10-24
Date Terminated2015-03-16
Product Quantity142 units

Reason for Recall

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

Firm Action

Dealers were contacted by Agfa HealthCare via phone and/or email on 10/24/2014 and the week of 11/10/14 to inform them of the quality issue and to quarantine identified product shipped to their facility or end users. On 11/17/2014, an "URGENT SAFETY NOTICE" letter was sent to the US dealers. The letter described the safety alert and the request to quarantine affected product. Acknowledgment via FAX-Back or email that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so they could sent it to the end use customers.

Root Cause

Other

Distribution Pattern

US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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