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

초록

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