Fujifilm FDR Go Plus mobile X-ray system
FDA Recall Z-2441-2019 · Posted None
Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2019-07-19
Date Terminated2020-08-28
Product Quantity174 units
Reason for Recall
The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
Firm Action
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:[email protected]
Root Cause
Software design
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.