1. U.S. Food and Drug Administration. Medical devices. List of device recalls. Available at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm . Accessed 29 June 2012.
2. Code of Federal Regulations. Title 21. Subpart C. Section 7.40. Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities.
3. U.S. Food and Drug Administration. FDA 101: product recalls: from first alert to effectiveness checks. http://www.fda.gov/consumer . Accessed 29 June 2012.
4. Swerdlow, C. D., Gunderson, B. D., Ousdigian, K. T., et al. (2010). Downloadable software algorithm reduces inappropriate shocks caused by implantable cardioverter-defibrillator lead fractures. A prospective study. Circulation, 122, 1449–1455.
5. Code of Federal Regulations (21CFR812.2).