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Volumn 47, Issue 6, 2013, Pages 514-522

Software-related recalls: An analysis of records

Author keywords

[No Author keywords available]

Indexed keywords

MEDICAL DEVICE INDUSTRY; MEDICAL DEVICES;

EID: 84891852266     PISSN: 08998205     EISSN: 19435967     Source Type: Journal    
DOI: 10.2345/0899-8205-47.6.514     Document Type: Article
Times cited : (18)

References (13)
  • 1
    • 84891862267 scopus 로고
    • May Some information available at: Accessed Oct. 30, 2013. For report, contact: dsmica@cdrh.fda.gov
    • U.S. Food and Drug Administration. Evaluation of Software Related Recalls for Fiscal Years 1983-91. May 1992. Some information available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ RecallsCorrectionsAndRemovals/. Accessed Oct. 30, 2013. For report, contact: dsmica@cdrh.fda.gov.
    • (1992) Evaluation of Software Related Recalls for Fiscal Years 1983-91
  • 2
    • 84891887594 scopus 로고    scopus 로고
    • GAO-11-468, June 14, Available at: Accessed March 2013
    • U.S. Government Accountability Office. FDA Should Enhance Its Oversight of Recalls. GAO-11-468, June 14, 2011. Available at: www.gao.gov/products/GAO- 11-468. Accessed March 2013.
    • (2011) FDA Should Enhance Its Oversight of Recalls
  • 3
    • 79959297420 scopus 로고    scopus 로고
    • Available at: Accessed March 2013
    • U.S. Food and Drug Administration. Medical & Radiation Emitting Device Recalls. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/ res.cfm. Accessed March 2013.
    • Medical & Radiation Emitting Device Recalls
  • 4
    • 84855720327 scopus 로고    scopus 로고
    • Available at: Accessed March 2013
    • U.S. Food and Drug Administration. Enforcement Reports. Available at: www.fda.gov/Safety/Recalls/EnforcementReports/default.htm. Accessed March 2013.
    • Enforcement Reports
  • 5
    • 84891866966 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. August For report, contact: dsmica@cdrh.fda.gov
    • U.S. Food and Drug Administration. Software Related Recalls for Fiscal Years 1992-1998. August 2000. For report, contact: dsmica@cdrh.fda.gov.
    • (2000) Software Related Recalls for Fiscal Years 1992-1998
  • 9
    • 84864058685 scopus 로고    scopus 로고
    • Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
    • doi:10.1371/journal.pone.0040200
    • Kramer DB, Baker M, Ransford B, Molina-Markham A, et al. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance. PLoS ONE 2012;7(7):e40200. doi:10.1371/journal.pone.0040200.
    • (2012) PLoS ONE , vol.7 , Issue.7
    • Kramer, D.B.1    Baker, M.2    Ransford, B.3    Molina-Markham, A.4
  • 10
    • 77954394159 scopus 로고    scopus 로고
    • An Analysis of Software Related Recalls of Medical Devices
    • Yang H, Hyman WA. An Analysis of Software Related Recalls of Medical Devices. Journal of Clinical Engineering. 2010:35,153-156.
    • (2010) Journal of Clinical Engineering , vol.35 , pp. 153-156
    • Yang, H.1    Hyman, W.A.2
  • 12
    • 84855745025 scopus 로고    scopus 로고
    • Available at: Accessed March 2013
    • U.S Food and Drug Administration. Recalls, Corrections and Removals (Devices). Available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ PostmarketRequirements/RecallsCorrectionsAndRemovals/. Accessed March 2013.
    • Recalls, Corrections and Removals (Devices)
  • 13
    • 84891854232 scopus 로고    scopus 로고
    • Available at: Accessed March 2013
    • U.S Food and Drug Administration. Device Classification Panels. Available at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ ClassifyYourDevice/ucm051530.htm. Accessed March 2013.
    • Device Classification Panels


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.