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Reflexion Medical, Inc.
2 federal recalls on file. 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.
- 2025-09-10FDA-DeviceClass IIRefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 i
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
- 2024-06-05FDA-DeviceClass IIRefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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