Slashdot Mirror
FDA: Software Failure Behind 24% of Last Year's Medical Device Recalls
chicksdaddy writes "Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration's (FDA's) Office of Science and Engineering Laboratories (OSEL). The absence of solid architecture and 'principled engineering practices' in software development affects a wide range of medical devices, with potentially life-threatening consequences, the FDA warned. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design."
The MRI machine I use has a complete circuit diagram along with design notes in a binder set next to the machine. In the US, you get the hardware manual for service. I don't believe the same is true for Europe and I have no idea about the rest of the world.