Analysis and classification of medical device recalls

IFMBE Proceedings

Volumn 14, Issue 1, 2007, Pages 3782-3785

  Bliznakov, Z ^a   Mitalas, G ^a   Pallikarakis, N ^a  

^a UNIVERSITY OF PATRAS   (Greece)

Author keywords

FDA records; Medical devices; Recalls; Software failures; Vigilance

Indexed keywords

BIOMEDICAL ENGINEERING; MEDICAL PROBLEMS; QUALITY CONTROL;

FDA RECORDS; MEDICAL DEVICES; RECALLS; SOFTWARE FAILURE; VIGILANCE;

BIOMEDICAL EQUIPMENT;

EID: 84958255099     PISSN: 16800737     EISSN: 14339277     Source Type: Conference Proceeding    
DOI: 10.1007/978-3-540-36841-0_957     Document Type: Conference Paper

References (4)

1. Andersen P (2003). A suggestion for guidance to the Medical Devices Community on the use of software validation and approval, In Proceedings of the Medical Device Software Workshop, EC Joint Research Centre, Ispra, Italy.
2. Pallikarakis N (2003) Medical Devices Software. In Proceedings of the Medical Device Software Workshop, EC Joint Research Centre, Ispra, Italy.
3. U.S. Food and Drug Administration Enforcement Reports. http://www.fda.gov/opacom/Enforce.html.
4. Wallace D, Kuhn D (2001) Failure Modes in Medical Device Software: an Analysis of 15 Years of Recall Data, Int J Reliab, Quality, and Safety Engineering, vol. 8(4).