Reflexion Medical recalls X1 Radiotherapy System Model RXM1000 with software versions 2.1.29-4 and 2.1.35-1 due to potential dose misdelivery. Affected units may receive 5mm+ displacement or 10-20% underdose.
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Reflexion Medical is recalling its X1 Radiotherapy System Model RXM1000 with specific software versions because a software defect can cause radiation treatment to be delivered to the wrong body area. This could result in a 5mm or larger displacement of the treatment or a 10-20% underdose of radiation, potentially affecting treatment effectiveness.
The software defect causes the system to not properly carry over roll corrections from the initial scan to the treatment delivery phase. This means radiation doses may be delivered to the wrong body location, potentially causing a 5mm or greater displacement of the treatment or a 10-20% underdose of radiation.
Patients receiving radiation therapy using the recalled X1 Radiotherapy System Model RXM1000 with specific software versions are most at risk. Healthcare facilities that use this equipment for cancer treatment may also be affected.
Check if your X1 Radiotherapy System Model RXM1000 has software versions 2.1.29-4 or 2.1.35-1. The unique device identifier (UDI) codes listed in the recall notice also identify affected units.
Verify your system's software version matches the affected versions listed in the recall notice.
Reach out to Reflexion Medical for guidance on next steps if your system is affected.
Software versions 2.1.29-4 and 2.1.35-1 are affected.
Check if your X1 Radiotherapy System Model RXM1000 has software versions 2.1.29-4 or 2.1.35-1, or if your unique device identifier (UDI) matches the listed codes.
Contact Reflexion Medical for guidance on next steps if your system is affected.
We’ve drafted a message you can send Reflexion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2026 — Reflexion Medical Reflexion Medical Hello, I own a Reflexion Medical that is covered by recall Z-1656-2026 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.
