Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015.

Abstract

To assess class I radiological device recalls using the FDA medical device recall database and provide a detailed analysis, including recall trends, regulatory changes, and policy implications for the future. This institutional review board-exempt study utilized the FDA Center for Devices and Radiological Health database for class I diagnostic radiological device recalls from November 1, 2002 to July 12, 2015. Recall characteristics, as well as market entry data, were collected for each device.