PubMed

Radiation Oncology Device Recalls (2015-2025): Software and Artificial Intelligence as Emerging Drivers of Postmarket Safety.

PMID: 42752054 · 2026-06-22

M, a, r, i, a, m, , R, o, w, e, ;, , D, y, l, a, n, , R, o, w, e

学術誌Practical radiation oncology

年2026-06-22

PMID42752054

抄録

Radiation oncology (RO) relies on complex devices spanning simulation, planning, delivery, and verification, making postmarket surveillance critical. Prior analyses of U.S. Food and Drug Administration (FDA) recalls (2002-2015) demonstrated a high recall burden, predominantly driven by software-related failures. Following recent technological advances, including rapid expansion of software systems and artificial intelligence (AI)-enabled tools, we analyzed RO device recalls from 2015 to 2025 to

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