RecallDepth

Fujifilm FDR Go Plus mobile X-ray system

Company
Fujifilm Medical Systems U.S.A., Inc.
Recall Initiated
July 19, 2019
Terminated
August 28, 2020
Recall Number
Z-2441-2019
Quantity
174 units
Firm Location
Lexington, MA

Reason for Recall

The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)

Distribution

Nationwide

Lot / Code Info

All serial numbers

Root Cause

Software design

Action Taken

Fuji Film issued notifications via FedEx standard overnight mail on July 19, 2019 advising of the problem, health risk and action to take: During this field action, you can continue to use your current FDR Go PLUS by following these additional instructions:1. Set the monitor sleep mode to Off. Complete the Field Action Verification Form, and upon receipt FUJIFILM service personnel will contact you to schedule a visit to correct your device.FUJIFILM will correct your affected device(s) by applying a registry file to your current software version, at no cost to you.. Question contact: Field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email mailto:jeffrey.wan@fujifilm.com

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