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Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.

PMID: 28463163 · 2017-02-12

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학술지International journal of radiation oncology, biology, physics

연도2017-02-12

PMID28463163

초록

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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