Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2087-2015Class II

RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC...

Eizo Corporation / initiated 2015-07-07 / Terminated / root cause: design

Eizo Corporation began a recall of RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in... on . FDA classified it as Class II and gives the reason as "EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2087-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eizo Corporation
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.
Product code
PGY Display, Diagnostic Radiology
Reason for recall
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Root cause tag
design
FDA root cause
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, [email protected], 5710 Warland Drive, Cypress, CA 90630).
Quantity in commerce
19 units
Distribution
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
Product codes and lots
21839093 21840093 21841093 21845093 21849093 21850093 21851093 21855093 21856093 21861093 23641024 24340064 24343064 24347064 24358064 24359064 24368064 24728094 24736094 25103104 25104104 25127104 25129104

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2087-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2087-2015Class IITerminatedVoluntary: Firm initiated
Z-2088-2015Class IITerminatedVoluntary: Firm initiated
Z-2089-2015Class IITerminatedVoluntary: Firm initiated