IBM / Safe Patients Means Dependable Software / Random House Inc. / Prevention Detection Software / The FDA / IEEE Software / Change / High Integrity Software / / /
Event
Product Issues / Product Recall / /
Facility
National Institute of Standards and Technology / D. Richard Kuhn Information Technology Laboratory National Institute of Standards and Technology Gaithersburg / National Institute / General Hospital / /
IndustryTerm
software engineering / appropriate master tools / software module / software development processes / software algorithm / software problems / configuration management / medical devices / software quality practices / system failures involving software / software technologies / obvious software fault / software quality assurance / software versions / software components / software modules / computer software problems / realtime applications / financial management / computer technology / external device / software revision / software component / software development / software configurations / the recall number or the product / software faults / software artifacts / final product / software recalls / medical device manufacturer adding software / software-based failures / proposed software engineering principles / display device / consumer products / correct algorithm / anesthesia gas machines / telecommunications / software experience / software fault / software system failures / improper software versions / computer software / ultrasound imaging systems / software programs / appropriate algorithms / chemical action / earlier similar devices / e - commerce / hardware-software systems / software program / software development practices / software quality practice / electrosurgical devices / /
Organization
Space Flight Center / Food and Drug Administration / Institute of Standards and Technology Gaithersburg / National Institute of Standards and Technology / FDA / National Aeronautics and Space Administration / General Hospital / /
Person
Mark Zimmerman / Henry Petroski / Michael Koo / Larry Reeker / Laura M. Ippolito / Lynn Elliott / D. Richard Kuhn / Barbara Cuthill / / /
Position
General / Engineer / general quality practices / author / CM manager / Porter / programmer / /
Product
software / data The FDA recall data / medical devices / program / system / /
Lessons from 342 Medical Device Failures Dolores R. Wallace and D. Richard Kuhn Information Technology Laboratory National Institute of Standards and Technology Gaithersburg, MDUSA ,