Reflexion Medical recalls X1 Radiotherapy System software version 2.1.19-3 due to potential dose errors for patients treated with out-of-session SCINTIX partial fractions. Affected units have specific UDI codes.
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Reflexion Medical is recalling its X1 Radiotherapy System software version 2.1.19-3 because it may cause incorrect radiation doses for patients receiving treatment with out-of-session SCINTIX partial fractions. This could lead to improper treatment outcomes if not corrected.
The software version 2.1.19-3 may cause dose errors when patients are treated with out-of-session SCINTIX partial fractions. This could result in improper radiation delivery during treatment, potentially affecting treatment effectiveness or safety.
Patients receiving radiation therapy using the affected software version may be at risk of incorrect treatment doses. Healthcare providers using the system with SCINTIX partial fractions are most impacted.
Check for the software version 2.1.19-3 on your RefleXion X1 Radiotherapy System. Affected units have specific UDI codes listed in the recall notice.
Verify your software version by checking the system settings or documentation.
The recalled software version is 2.1.19-3.
Check for the UDI codes listed in the recall notice: (01)00860003983812(11)230504(21)X11001 through (01)00860003983812(11)230803(21)X11008.
The recall notice does not specify a remedy.
We’ve drafted a message you can send Reflexion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1933-2024 — Reflexion Medical Reflexion Medical Hello, I own a Reflexion Medical that is covered by recall Z-1933-2024 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.
