Literature DB >> 24328977

Software-related recalls: an analysis of records.

Lisa K Simone.   

Abstract

Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges faced in determining the causes, and examples and trends in software-related recalls. This information can be useful in enhancing our understanding of why medical devices fail, and it can help to improve medical device safety, and patient and public health.

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Year:  2013        PMID： 24328977     DOI： 10.2345/0899-8205-47.6.514

Source DB:  PubMed          Journal:  Biomed Instrum Technol        ISSN： 0899-8205


  5 in total

1.  Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.

Authors:  Michael J Connor; Deborah C Marshall; Vitali Moiseenko; Kevin Moore; Laura Cervino; Todd Atwood; Parag Sanghvi; Arno J Mundt; Todd Pawlicki; Abram Recht; Jona A Hattangadi-Gluth
Journal:  Int J Radiat Oncol Biol Phys       Date:  2017-01-01       Impact factor: 7.038

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

Authors:  Michael J Connor; Kathryn Tringale; Vitali Moiseenko; Deborah C Marshall; Kevin Moore; Laura Cervino; Todd Atwood; Derek Brown; Arno J Mundt; Todd Pawlicki; Abram Recht; Jona A Hattangadi-Gluth
Journal:  Int J Radiat Oncol Biol Phys       Date:  2017-02-12       Impact factor: 7.038

3.  Unreliable numbers: error and harm induced by bad design can be reduced by better design.

Authors:  Harold Thimbleby; Patrick Oladimeji; Paul Cairns
Journal:  J R Soc Interface       Date:  2015-09-06       Impact factor: 4.118

4.  "Usability of data integration and visualization software for multidisciplinary pediatric intensive care: a human factors approach to assessing technology".

Authors:  Ying Ling Lin; Anne-Marie Guerguerian; Jessica Tomasi; Peter Laussen; Patricia Trbovich
Journal:  BMC Med Inform Decis Mak       Date:  2017-08-14       Impact factor: 2.796

5.  Improvements in Medical System Safety Analytics for Authentic Measure of Vital Signs Using Fault-Tolerant Design Approach.

Authors:  Prasadraju Lakkamraju; Madhu Anumukonda; Shubhajit Roy Chowdhury
Journal:  Front Med Technol       Date:  2021-08-25
  5 in total

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