Medical device recalls : an overview and analysis 1983-88: report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives
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aData adverse health consequences Amendments of 1976 Anesthesia machine Anesthesiology appendix lV aThe numbers based are contained battery cardiac cardiac pacemakers cause cdrh class I recalls Class II Medium Classification of Recalls consequences or death contained in table controls crib data bases defibrillator device classes device reporting regulation devices for example dialysate failure FDA recall data figure is based fiscal years 1983 Gastroenterology hemodialysis High risk hypoxia least serious malfunction manufacturer manufacturing practices Medical Device Amendments medical device recalls medical device reporting medical practice specialties Medical specialty Medium Serious medium-risk devices most-serious Number and Classification Number of Recalls patients Percent of Recalls Percent recalls Percent performance standards postmarketing surveillance Potential product recall recall classes recall data tape recall process recalled devices Recalls by Device Recalls by Recall recalls Percent recalls Replacement heart valve Reporting Regulation Report safety and effectiveness serious adverse health Source U.S. General Accounting urology violative product