Recall Z-2294-2020— Eizo Corporation

Name: FDA recall Z-2294-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-30

Class II · Ongoing

Class II FDA medical device recall by Eizo Corporation, initiated 2019-07-30. It names one FDA 510(k) clearance: K182591. 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.. Reason: Under certain conditions, a marble pattern infrequently appears on the monitor..

Recalling firm: Eizo Corporation
Classification: Class II
Status: Ongoing
Initiated: 2019-07-30
Firm location: Hakusan, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K182591 — RadiForce RX360, RX360-AREizo Corporation·cleared 2018-10-18

K-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 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.

Reason for recall

Under certain conditions, a marble pattern infrequently appears on the monitor.

Data sourced from openFDA. This site is unofficial and independent of the FDA.