Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2089-2015Class II

RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended...

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

Eizo Corporation began a recall of RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital... 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-2089-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eizo Corporation
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.
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
2 units
Distribution
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
Product codes and lots
220045044, 20050044

Enforcement reports

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