Reflexion Medical, Inc. recalls
3 federal recalls on file, showing the 1 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Reflexion Medical, Inc. 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
RefleXion Medical's X1 Radiotherapy System has a software defect that can cause radiation treatment to be delivered to the wrong location when certain positioning corrections are made. This may result in radiation doses being delivered 5mm or more away from the intended target, with possible underdosing of 10% to 20%. The issue affects 12 systems running specific software versions.
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