Recall Z-2088-2015— Eizo Corporation
Class II · Terminated
Class II FDA medical device recall by Eizo Corporation, initiated 2015-07-07, terminated 2016-11-30. It names one FDA 510(k) clearance: K134002. Product: RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.. Reason: EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort..
- Recalling firm
- Eizo Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-07
- Terminated
- 2016-11-30
- Firm location
- Hakusanshi, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Reason for recall
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Data sourced from openFDA. This site is unofficial and independent of the FDA.