title: Overview of Class I Device Recalls in Diagnostic Radiology, 2002-2015.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Radiology, University of Chicago, Chicago, Illinois. Electronic address: Comeron.Ghobadi@uchospitals.edu.
authors.forename: Comeron W
authors.initials: CW
authors.lastname: Ghobadi
authors.affiliation: Department of Radiology, Northwestern University, Chicago, Illinois.
authors.forename: Emily L
authors.initials: EL
authors.lastname: Hayman
authors.affiliation: Department of Dermatology, Northwestern University, Chicago, Illinois.
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
mesh_terms: D006801:Humans; D057052:Medical Device Recalls; D011871:Radiology; D014481:United States; D014486:United States Food and Drug Administration
keywords: 21st Century Cures Act; FDA; Medical device recall; health policy; medical device regulation; patient safety