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Reflexion Medical, Inc.

Reflexion Medical, Inc. Recalls

All product recalls associated with Reflexion Medical, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

RefleXion X1 (Reflexion Medical) – Software Configuration Risk (2025)

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

Moderate

FDAJul 22, 2025Nationwide• Reflexion Medical, Inc.

Reflexion Medical, Inc.: RefleXion X1 Radiotherapy System Model RXM1000 Software v...

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

Moderate

FDAApr 16, 2024CA, CT, NJ +3 more• Reflexion Medical, Inc.