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

Comeron W. Ghobadi*, Emily L. Hayman, Shuai Xu

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Purpose 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. Methods 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. Results Thirteen class I radiological device recalls were identified, with 12 of them occurring after 2011. SPECT nuclear medicine systems were the most common, followed by fluoroscopic x-ray and MRI systems. Eleven of the recalls were attributed to premarket-related issues. One recall event occurred in response to the death of a patient during a nuclear scan. Twelve of the devices were cleared under the 510(k) pathway. A median of 213 devices (range: 2 to 12,968) were recalled per event, and all but two devices had a worldwide distribution at the time of recall. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)638-643
Number of pages6
JournalJournal of the American College of Radiology
Volume13
Issue number6
DOIs
StatePublished - Jun 1 2016

Keywords

  • 21st Century Cures Act
  • FDA
  • Medical device recall
  • health policy
  • medical device regulation
  • patient safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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