Lower risk Medical device recall · FDA · Published November 23, 2023

FUJIFILM Mobile X-Ray System Recall: Default Exposure Settings Risk

FUJIFILM Healthcare recalls mobile x-ray systems with default adult chest exposure settings that may cause incorrect imaging. Affected units have specific serial numbers from all shipments.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3158-2024Medical device FUJIFILM Healthcare ›

Lower-risk 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.

Take action

Contact the company

Recalling firmFUJIFILM Healthcare Americas Corporation81 Hartwell Ave, Ste 300 · Lexington, MA 02421-3160

✎ GovInfoNow plain-language explainer

FUJIFILM Healthcare is recalling mobile x-ray systems that set default exposure conditions for adult chest imaging. This could lead to incorrect medical images if the system is used without proper adjustments. Read more at govinfonow.com/recall/56771-fujifilm-mobile-x-ray-system-recall-default-exposure-settings-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56771-fujifilm-mobile-x-ray-system-recall-default-exposure-settings-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3158-2024

Cite this page

“FUJIFILM Mobile X-Ray System Recall: Default Exposure Settings Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56771-fujifilm-mobile-x-ray-system-recall-default-exposure-settings-risk. Based on FDA recall #Z-3158-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3158-2024%22&limit=1).

The FDA announced on November 23, 2023, that FUJIFILM Healthcare Americas Corporation is recalling its mobile x-ray system due to incorrect exposure settings. The agency issued recall number Z-3158-2024 for the device.

How to tell if you have it

Brand: FUJIFILM Healthcare
Product: 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
Quantity: 130 units

The hazard

According to the FDA, when the key switch is turned on, exposure conditions default to values intended for adult chest imaging. Additionally, if exposure conditions are set from the console while the key switch is off, those settings will not be reflected.

Context

GovInfoNow's records show FUJIFILM Healthcare Americas Corporation has 13 other recalls on record since October 14, 2021. Recent recalls include a July 22, 2026 recall for inaccurate ruler measurements in Synapse PACS Software v7.4.310 and a January 9, 2026 recall regarding overheating risks in the FDR Visionary Suite CH-200 X-ray Device. Other recent recalls of similar products include a June 5, 2026 column safety risk for the GE Optima XR200amx Mobile Radiography System and a November 18, 2025 recall for exceeding air kerma limits in the AGFA DR 800 X-Ray System.

How to tell if you have this one

The mobile x-ray system is part of Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE family. All units with serial numbers shipped from Fujifilm Healthcare Americas are affected.

Brand
FUJIFILM Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify the serial number on your device to confirm it was shipped from Fujifilm Healthcare Americas.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide and Worldwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 10 months after the firm started it.

Nov 23, 2023Firm started the recall
Sep 25, 2024FDA classified it Class II
Oct 2, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall involves a potential for incorrect imaging settings but does not pose a risk of injury or damage to users.

What should I do if I have this device?

The recall does not require immediate action; check your serial number to confirm if affected.

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Link to this recall

<a href="https://govinfonow.com/recall/56771-fujifilm-mobile-x-ray-system-recall-default-exposure-settings-risk">FUJIFILM Mobile X-Ray System Recall: Default Exposure Settings Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3158-2024 (November 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3158-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.