Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation Recalled by Reflexion Medical, Inc. Due to A potential dose error exists for patients treated...
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 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.
Quantity: 7 systems
Why Was This Recalled?
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Where Was This Sold?
This product was distributed to 6 states: CA, CT, NJ, OR, PA, TX
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