The device is a mobile x-ray system designed to work with… recallZ-3158-2024 · FUJIFILM Healthcare Americas Corporation · initiated Nov 23, 2023
Class II Open, Classified All recalls posted in September 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-3158-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2023
- Posted by the FDA
- Sep 25, 2024
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 130
- Product code
- IZL
- FDA submissions
- K170858
- Distribution
- US Nationwide and Worldwide
Product description
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.
Code information (models, lots, serial numbers)
All serial numbers shipped from FUJIFILM
Other devices under the same FDA submission
1 device cleared under K170858 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FDR AQRO DR-XD 1000Fujifilm Corporation · System, x-ray, mobile1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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