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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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.
A radiotherapy software defect can cause roll corrections from an initial localization to not be applied during treatment delivery. This can displace the delivered dose by 5 millimeters or more and reduce the intended dose by 10 to 20 percent.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Reflexion Medical or your healthcare provider for instructions. 3. Follow the recall instructions issued by Reflexion Medical. 4. Do not operate the device until advised by clinical leadership.
Information below is based on the recall notice. Specific contact details are not provided in the summary data.
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