Reflexion Medical recalled 12 RefleXion X1 Radiotherapy System RXM1000 units sold to hospitals and healthcare providers in the United States after a software defect could cause a 5mm or greater misalignment and underdose. The defect occurs during angular roll corrections followed by a repeat localization, and the roll corrections from the initial localization are not carried through to treatment.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Reflexion Medical, Inc. or your healthcare provider for instructions
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The RefleXion X1 Radiotherapy System is a high-precision device used in cancer treatment to deliver targeted radiation therapy. It is deployed in hospitals and cancer centers under physician supervision.
A software defect during correction steps can cause roll corrections from the initial localization to not carry through to treatment delivery. This can shift the radiation dose away from the intended target by about 5 mm or more and reduce the delivered dose by 10% to 20%.
This recall is not described as part of a broader industry pattern in the provided data.
The recall creates a potential safety risk for patients undergoing radiotherapy and imposes operational considerations for hospitals, without any reported injuries to date.
Device labels, maintenance records, and electronic medical records may contain software version, part numbers, and UDI identifiers.
Remediation timelines vary by hospital and vendor processes. No consumer refund timeline is provided for this medical device recall.
Keep a copy of the recall notice, device serial numbers, software versions, UDIs, and all correspondence with the manufacturer and hospital leadership.
Model: RefleXion X1 Radiotherapy System RXM1000; Part #: 800-00006-00. Sold to hospitals and healthcare providers in the United States. Quantity: 12 units. No price information available.
No injuries or incidents have been reported.
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