FDA-Device2022-01-19Class II
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Reflexion Medical, Inc.
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).
Sold states
U.S. Nationwide distribution in the states of CA and TX
Affected count
3 devices
Manufactured in
25881 Industrial Blvd, N/A, Hayward, CA, United States
Products
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2022Don't want to check this manually?
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