2 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
FDA Recall
Terminated
·Reflexion Medical, Inc.·Product code IYE·November 24, 2021
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
FDA Enforcement
Class II
·Terminated·Reflexion Medical, Inc.·January 19, 2022