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Recall Observatory FDA recall evidence

Device product

Fujifilm FDR Go Plus mobile X-ray system

Z-2441-2019

July 19, 2019

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 83524
Status
Terminated
Classification
Class II
Quantity
174 units
Official record key
device-enforcement:Z-2441-2019

Official wording

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

Code information: All serial numbers

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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