CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
The device is a mobile x-ray system designed to work recalled
Fujifilm Healthcare Americas is recalling The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI, distributed nationwide in the US. The recall was initiated on 23 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3158-2024
- FDA event ID
- 95320
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Nov 2023
- FDA classified
- 25 Sep 2024
- Reported
- 2 Oct 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 23 Nov 2023 | Recall initiated by company | |
| 25 Sep 2024 | Classified by FDA | +307 days |
| 2 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide and Worldwide
Questions about this recall
Why was it 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.
Which lots are affected?
All serial numbers shipped from FUJIFILM
Where was it sold?
US Nationwide and Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fujifilm Healthcare Americas
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|---|---|---|---|---|---|
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| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Other | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 8 states |
| Device | CLASS II | Asprire Cristalle Mammography System recalled | Fujifilm Healthcare Americas | Device Malfunction | Nationwide |
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