Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF Recalled by Reflexion Medical, Inc. Due to Due to dose discrepancy when delivering a plan...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Reflexion Medical, Inc. directly.
Affected Products
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Quantity: 3 devices
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Reflexion Medical, Inc.
Reflexion Medical, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report