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Class 3 Device Recall Medical Screen Film Radiomat M Plus |
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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
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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/ Manufacturer |
AGFA Healthcare Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact |
Debbie Huff 864-421-1754
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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