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U.S. Department of Health and Human Services

Class 2 Device Recall RadiForce GX540

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  Class 2 Device Recall RadiForce GX540 see related information
Date Initiated by Firm July 07, 2015
Date Posted July 16, 2015
Recall Status1 Terminated 3 on November 30, 2016
Recall Number Z-2087-2015
Recall Event ID 71628
510(K)Number K130336  
Product Classification Display, diagnostic radiology - Product Code PGY
Product RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752.
This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
Code Information 21839093 21840093 21841093 21845093 21849093 21850093 21851093 21855093 21856093 21861093 23641024 24340064 24343064 24347064 24358064 24359064 24368064 24728094 24736094 25103104 25104104 25127104 25129104
Recalling Firm/
Manufacturer		 Eizo Corporation
153
Shimokashiwano
Hakusanshi Japan
Manufacturer Reason
for Recall		 EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
FDA Determined
Cause 2		 Device Design
Action EIZO sent An Urgent Field Safety Notice dated July 7, 2015, to all customers who purchased the RadiForce RX440, RX650, RX850 and GX540. The notice informs customers that the RadiForce monitors could display abornormally in 6-bit (64 gradations) instead of normal 8-bit (256 gradations) or 10-bit (1024 gradations) while connecting to particular graphics boards with DisplayPort. The notice provides the customers with the actions to be taken and contact information (1-800-800-5202, M-F, 8am-4pm, PST, us.feedback@eizo.com, 5710 Warland Drive, Cypress, CA 90630).
Quantity in Commerce 19 units
Distribution Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
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.
510(K) Database 510(K)s with Product Code = PGY and Original Applicant = EIZO NANAO CORPORATION
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