Z-2441-2019Class II

Fujifilm FDR Go Plus mobile X-ray system

Name: Z-2441-2019 Fujifilm FDR Go Plus mobile X-ray system
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2019-07-19
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2019-07-19 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Fujifilm FDR Go Plus mobile X-ray system on 2019-07-19. FDA classified it as Class II and gives the reason as "The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2441-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-19
Posted: 2019-08-30
Terminated: 2020-08-28
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujifilm FDR Go Plus mobile X-ray system
Product code: IZL System, X-Ray, Mobile
Reason for recall: The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
Root cause tag: software
FDA root cause: Software design
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]
Quantity in commerce: 174 units
Distribution: Nationwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2441-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2441-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code IZL

K080701Class IIShimadzu Mobile X-Ray System Mobiledart EvolutionShimadzu Corp. / cleared 2008-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)