Reflexion Medical recalls specific models of X1 radiation therapy systems due to software configuration that could allow more than two fractions in 12 hours, potentially causing toxicity. Affected units have unique UDI codes listed.
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
Reflexion Medical is recalling specific models of their X1 radiation therapy systems because of a software issue that might let the device deliver more than two treatment fractions within a 12-hour period. This could lead to toxicity in patients receiving radiation therapy.
The software configuration error allows the device to process more than two treatment fractions within a 12-hour period. This could result in patients receiving an excessive radiation dose, potentially causing toxicity or adverse health effects.
Patients receiving radiation therapy using the recalled RefleXion X1 models are most at risk. Healthcare facilities that use these devices for oncology treatment may also be affected.
Check the UDI codes on your device. Affected units have specific serial numbers starting with (01)00860003983812 followed by a date code and model number (e.g., (11)230504(21)X11001).
Look for the unique device identifier codes on your RefleXion X1 model. Affected units have specific UDI codes listed in the recall notice.
The software configuration allows more than two treatment fractions within a 12-hour period, which could lead to toxicity in patients.
Check the UDI codes on your device. Affected units have specific serial numbers starting with (01)00860003983812 followed by a date code and model number (e.g., (11)230504(21)X11001).
No, but you should check the UDI codes to see if your device is affected. The recall does not require immediate discontinuation but requires verification of the device's serial number.
We’ve drafted a message you can send Reflexion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2486-2025 — Reflexion Medical Reflexion Medical Hello, I own a Reflexion Medical that is covered by recall Z-2486-2025 from Reflexion Medical. 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.
