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Reflexion Medical, Inc. recalls RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Del
Recalled January 19, 2022 · FDA recall Z-0470-2022 · Reflexion Medical
Hazard
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS). · FDA Class II
Units
3 devices
Sold at
U.S. Nationwide distribution in the states of CA and TX
Description
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Product
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Manufacturer(s)
Reflexion Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →