Z-3158-2024Class II

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2...

Name: Z-3158-2024 The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2...
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2023-11-23
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2023-11-23 / Open, Classified

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors... on 2023-11-23. FDA classified it as Class II and gives the reason as "When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3158-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-23
Posted: 2024-09-25
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Product code: IZL System, X-Ray, Mobile
Reason for recall: When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.
FDA root cause: Radiation Control for Health and Safety Act
Action: Customer and Dealer notification will occur by means of letters alerting customers and dealers to the potential for overexposure to children if the conditions are not checked after the key switch is turned on. The notices also include the plan for the affected mobile x-ray systems. The system will be upgraded, free of charge, with updated software so that the exposure values set by the user are reflected regardless of the state of the key switch.
Quantity in commerce: 130
Distribution: US Nationwide and Worldwide
Product codes and lots: All serial numbers shipped from FUJIFILM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3158-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3158-2024	Class II	Ongoing	FDA Mandated	2024-10-02	2024-09-25

Product code IZL

K170858Class IIFdr Aqro (Dr-Xd 1000)Fujifilm Medical Systems U.S.A, Inc. / cleared 2017-04-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)