Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.
PMID: 28463163 ·
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Resumen
To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), q
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