Journal of the American College of Radiology : JACR
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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. ⋯ We found that policy changes to the FDA were temporally related to class I radiological recall events. Additionally, class I radiological device recalls share characteristics: device modality, reason for recall, market entry, and product distribution. These recalls have broad implications and highlight the need for continued regulatory oversight as imaging technologies continue to advance.