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U.S. Department of Health and Human Services

Class 3 Device Recall Medical Screen Film Radiomat M Plus

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  Class 3 Device Recall Medical Screen Film Radiomat M Plus see related information
Date Initiated by Firm October 24, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-0804-2015
Recall Event ID 69864
Product Classification Film, radiographic - Product Code IWZ
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
Code Information Lot 79440009
Recalling Firm/
AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
Manufacturer Reason
for Recall
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
FDA Determined
Cause 2
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.
Quantity in Commerce 142 units
Distribution US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.