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.
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.
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.
The system defaults to adult chest imaging settings (85kV, 1.6 mAs) when turned on. If exposure settings are changed while the key switch is off, those changes won't save the new settings for later use.
Healthcare facilities using the mobile x-ray system are most likely affected. Patients receiving scans with this system may receive incorrect images if settings aren't adjusted.
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.
Verify the serial number on your device to confirm it was shipped from Fujifilm Healthcare Americas.
The recall involves a potential for incorrect imaging settings but does not pose a risk of injury or damage to users.
Check if your device is part of Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE family with a serial number shipped from Fujifilm Healthcare Americas.
The recall does not require immediate action; check your serial number to confirm if affected.
We’ve drafted a message you can send FUJIFILM Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3158-2024 — FUJIFILM Healthcare FUJIFILM Healthcare Hello, I own a FUJIFILM Healthcare that is covered by recall Z-3158-2024 from FUJIFILM Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
