Error Types and Associations of Clinically Significant Events Within Food and Drug Administration Recalls of Linear Accelerators and Related Products.

Abstract

Medical devices in radiation therapy undergo a complex process of Food and Drug Administration (FDA) approval. Little is known about which processes within the radiation therapy medical device industry are most prone to events involving wrong dose, volume, or targeting in radiation therapy treatment. We carried out a retrospective analysis of the United States FDA Medical Device Recalls database for recalls of products classified as "Accelerator, Linear, Medical" from 2010 to 2016. Each recall e