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U.S. Department of Health and Human Services

Class 3 Device Recall Radiomat B Plus, Radiomat M Plus, radiomat G Plus, Radiomat SG, RXB and Curix UVG Plus

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  Class 3 Device Recall Radiomat B Plus, Radiomat M Plus, radiomat G Plus, Radiomat SG, RXB and Curix UVG Plus see related information
Date Initiated by Firm July 16, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on December 09, 2014
Recall Number Z-2178-2014
Recall Event ID 68844
Product Classification Film, radiographic - Product Code IWZ
Product Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF

Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Code Information Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
Recalling Firm/
Manufacturer		 AGFA Healthcare Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall		 Some sheets of the medical screen film are fogged.
FDA Determined
Cause 2		 Process design
Action On July 16, 2014, an "URGENT FIELD SAFETY NOTICE" letter was sent to the US and Canadian dealers (consignees). 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 that it could be sent to their customers.
Quantity in Commerce 2617
Distribution Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
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.
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