PubMed

Research: User Interface Software Errors in Medical Devices: Study of U.S. Recall Data.

PMID: 31162965 · 2019

Y, i, , Z, h, a, n, g, ;, , P, a, o, l, o, , M, a, s, c, i, ;, , P, a, u, l, , J, o, n, e, s, ;, , H, a, r, o, l, d, , T, h, i, m, b, l, e, b, y

学術誌Biomedical instrumentation & technology

年2019

PMID31162965

抄録

The current work assessed U.S. medical device recalls during 2012-15, with the goal of under-standing the impact and nature of user interface (UI) software errors in medical devices. Based on information from the Food and Drug Administration's public and internal recall databases, 423 (~140/year) medical device recalls were identified as resulting from UI software errors, which accounted for nearly one-half of recalls caused by software errors during the same period. A total of 499 UI software e

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