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Class 2 Device Recall RadiForce RX850 |
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Date Initiated by Firm |
July 07, 2015 |
Date Posted |
July 16, 2015 |
Recall Status1 |
Terminated 3 on November 30, 2016 |
Recall Number |
Z-2089-2015 |
Recall Event ID |
71628 |
510(K)Number |
K140702
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Product Classification |
Display, diagnostic radiology - Product Code PGY
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Product |
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners. |
Code Information |
220045044, 20050044 |
Recalling Firm/ Manufacturer |
Eizo Corporation 153 Shimokashiwano Hakusanshi Japan
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Manufacturer Reason for Recall |
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
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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 |
2 units |
Distribution |
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ. |
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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510(K) Database |
510(K)s with Product Code = PGY and Original Applicant = EIZO CORPORATION
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