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Reflexion Medical
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Reflexion Medical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IIContact RefleXion about X1 Radiotherapy System software update
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.
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