Class 2 Device Recall RadiForce RX360

• Date Initiated by Firm: July 30, 2019
• Create Date: June 08, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2294-2020
• Recall Event ID: 85299
• 510(K)Number: K182591
• Product Classification: Display, diagnostic radiology - Product Code PGY
• Product: RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
• Code Information: RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.
• FEI Number: 3000237660
• Recalling Firm/ Manufacturer: Eizo Corporation; Eizo ( Kabu ); Hakusan Japan
• For Additional Information Contact: Mr. Martin Ruiz; 562-431-5011 Ext. 154
• Manufacturer Reason for Recall: Under certain conditions, a marble pattern infrequently appears on the monitor.
• FDA Determined Cause: Device Design
• Action: EIZO Japan announced the recall on their website on 7/30/2019. EIZO U.S. began contacting their consignees via email and phone (one as early as 8/7/2019, some on 10/18/2019, but the majority on 11/26/2019) and began updating consignee monitors with the firmware. The notification requested the consignee contact EIZO U.S. for assistance with the firmware update.
• Quantity in Commerce: 1,466 monitors dist. to the U.S.
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin. Distribution was also made to Puerto Rico. There was no government/military consignees. The countries of Canada, Australia, Austria, Belgium, Brazil, China, Czech Republic, Egypt, France, Germany Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Pakistan, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PGY