Z-1040-2019Class II

Fujifilm FDR Go PLUS, Mobile X-Ray System

Name: Z-1040-2019 Fujifilm FDR Go PLUS, Mobile X-Ray System
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2019-01-15
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2019-01-15 / Terminated / root cause: design

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the... on 2019-01-15. FDA classified it as Class II and gives the reason as "FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1040-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-15
Posted: 2019-03-21
Terminated: 2020-10-08
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
Product code: IZL System, X-Ray, Mobile
Reason for recall: FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
Root cause tag: design
FDA root cause: Device Design
Action: Fujifilm sent an Urgent Medical Device Correction and Removal letter dated January 16, 2019 to customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to schedule a visit by our Service department to replace the handle assembly. Customers were provided with additional instructions to continue using the affected product safely until the correction was made. For questions call 201-675-8947.
Quantity in commerce: 56 units
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: MQ0001281001 through MQ0001285004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1040-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1040-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-21

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)